March 2000 510(k) Clearances

DEVICE: ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 T
ABBOTT LABORATORIES, INC.         510(k) NO: K000821(SPECIAL)
ATTN: JILL  SACKETT               PHONE NO : 847-937-4085
DEPT. 389, AP30                   SE DECISION MADE: 24-MAR-00
200 ABBOTT PARK ROAD              510(k) STATEMENT
ABBOTT PARK, IL 60064-3537

DEVICE: ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000
ACIST MEDICAL SYSTEMS             510(k) NO: K000013(SPECIAL)
ATTN: CARL M BEAURLINE            PHONE NO : 612-995-9319
7450 FLYING CLOUDS DR.            SE DECISION MADE: 28-MAR-00
SUITE 150                         510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344

DEVICE: PEGASYS ULTRA
ADAC LABORATORIES                 510(k) NO: K993946(TRADITIONAL)
ATTN: JANICE  BROWN               PHONE NO : 408-321-9100
540 ALDER DR.                     SE DECISION MADE: 09-MAR-00
MILPITAS, CA 95035                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
ADRI                              510(k) NO: K000054(TRADITIONAL)
ATTN: GEORGE H SCHERR             PHONE NO : 708-758-3242
P.O. BOX 134                      SE DECISION MADE: 13-MAR-00
PARK FOREST, IL 60466             510(k) STATEMENT

DEVICE: OTW MEGALINK SDS BILIARY STENT SYSTEM
ADVANCED CARDIOVASCULAR SYSTEMS, I510(k) NO: K000550(SPECIAL)
ATTN: SANDRA  SUNDELL             PHONE NO : 408-845-4278
3200 LAKESIDE DRIVE               SE DECISION MADE: 17-MAR-00
SANTA CLARA, CA 95054             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTE
ADVANTAGE MEDICAL ELECTRONICS, INC510(k) NO: K992524(TRADITIONAL)
ATTN: KENNETH E KENDRICKS         PHONE NO : 954-345-9800
10630 WILES RD.                   SE DECISION MADE: 01-MAR-00
CORAL SPRINGS, FL 33076           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AESCULAP BONE WAX
AESCULAP, INC.                    510(k) NO: K000021(TRADITIONAL)
ATTN: STEVE  REITZLER             PHONE NO : 619-977-1465
13221 MARICOTTE PLACE             SE DECISION MADE: 24-MAR-00
SAN DIEGO, CA 92130               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
AGILENT TECHNOLOGIES, INC.        510(k) NO: K000635(SPECIAL)
ATTN: MIKE  HUDON                 PHONE NO : 978-659-3173
3000 MINUTEMAN RD.                SE DECISION MADE: 20-MAR-00
ANDOVER, MA 01810-1099            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONVERTORS EQUIPMENT DRAPES
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K000417(TRADITIONAL)
ATTN: SHARON  ROBBINS             PHONE NO : 847-785-3311
1500 WAUKEGAN RD.                 SE DECISION MADE: 17-MAR-00
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHI
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K000697(SPECIAL)
ATTN: SHARON  ROBBINS             PHONE NO : 847-785-3311
1500 WAUKEGAN RD., MPWM           SE DECISION MADE: 30-MAR-00
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACME MEDICAL AESTHETIC ND:YAG LASER
ALTUS MEDICAL                     510(k) NO: K991798(TRADITIONAL)
ATTN: MICHAEL  LEVERNIER          PHONE NO : 650-552-9700
821 COWAN ROAD                    SE DECISION MADE: 06-MAR-00
BURLINGAME, CA 94010              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
AMERICAN DENTAL PRODUCTS, INC.    510(k) NO: K994368(TRADITIONAL)
ATTN: GEORGE  NICOLAE             PHONE NO : 630-238-0275
603-B COUNTRY CLUB DR.            SE DECISION MADE: 14-MAR-00
BENSENVILLE, IL 60106-1329        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAPLETAC2 BONE ANCHOR SYSTEM
AMERICAN MEDICAL SYSTEMS, INC.    510(k) NO: K000279(SPECIAL)
ATTN: SYLVIA L GUBBE              PHONE NO : 800-328-3881
10700 BREN RD., WEST              SE DECISION MADE: 01-MAR-00
MINNETONKA, MN 55343              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM
ANSELL PERRY INC.                 510(k) NO: K000165(TRADITIONAL)
ATTN: JAMES R CHATTERTON          PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E.           SE DECISION MADE: 10-MAR-00
MASSILLON, OH 44646-7199          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
APPLE MEDICAL CORP.               510(k) NO: K000026(TRADITIONAL)
ATTN: JOHN  PULFORD               PHONE NO : 800-255-2926
28 LORD RD., UNIT 135             SE DECISION MADE: 31-MAR-00
MARLBORO, MA 01752                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS C
ARROW INTL., INC.                 510(k) NO: K993691(TRADITIONAL)
ATTN: THOMAS D NICKEL             PHONE NO : 610-478-3137
2400 BERNVILLE ROAD               SE DECISION MADE: 08-MAR-00
READING, PA 19605                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWI
ARTHROCARE CORP.                  510(k) NO: K000511(SPECIAL)
ATTN: BRUCE  PROTHRO              PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 13-MAR-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISAGE COSMETIC SURGERY, MODEL V5000
ARTHROCARE CORP.                  510(k) NO: K992180(TRADITIONAL)
ATTN: BRUCE  PROTHRO              PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 20-MAR-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODULAP
ATC TECHNOLOGIES, INC.            510(k) NO: K994319(TRADITIONAL)
ATTN: MARIAN  HARDING COCHRAN     PHONE NO : 954-929-4317
1034 LINCOLN STREET               SE DECISION MADE: 20-MAR-00
HOLLYWOOD, FL 33019               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGE
ATL ULTRASOUND, INC.              510(k) NO: K994373(TRADITIONAL)
ATTN: TERRANCE J SWEEENEY         PHONE NO : 425-487-7602
P.O. BOX 3003                     SE DECISION MADE: 24-MAR-00
BOTHELL, WA 98041-3003            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANTA SUPER SOFT GRAFT
ATRIUM MEDICAL CORP.              510(k) NO: K000499(SPECIAL)
ATTN: KAREN  HALL                 PHONE NO : 603-880-1433
5 WENTWORTH DR.                   SE DECISION MADE: 01-MAR-00
HUDSON, NH 03051                  510(k) STATEMENT

DEVICE: ADVANTA SUPER SOFT GRAFT
ATRIUM MEDICAL CORP.              510(k) NO: K000504(SPECIAL)
ATTN: KAREN  HALL                 PHONE NO : 603-880-1433
5 WENTWORTH DR.                   SE DECISION MADE: 01-MAR-00
HUDSON, NH 03051                  510(k) STATEMENT

DEVICE: AVL OPTI R ANALYZER
AVL SCIENTIFIC CORP.              510(k) NO: K000103(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 770-576-5000
235 HEMBREE PARK DR.              SE DECISION MADE: 20-MAR-00
ROSWELL, GA 30076                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRASOUND SCANNER TYPE 2102
B & K MEDICAL A/S                 510(k) NO: K000567(SPECIAL)
ATTN: VILLY  BRAENDER             PHONE NO : 011 454 5970100
SANDTOFTEN 9                      SE DECISION MADE: 09-MAR-00
GENTOFTE, DENMARK DK-2820         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HORIZON LIGHT
B. BRAUN MEDICAL, INC.            510(k) NO: K994375(TRADITIONAL)
ATTN: GARY  GULYAS                PHONE NO : 972-245-2243
1601 WALLACE DR., SUITE 150       SE DECISION MADE: 08-MAR-00
CARROLLTON, TX 75006              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
B. BRAUN OF AMERICA, INC.         510(k) NO: K993024(TRADITIONAL)
ATTN: MARK S ALSBERGE             PHONE NO : 610-266-0500
901 MARCON BLVD.                  SE DECISION MADE: 13-MAR-00
ALLENTOWN, PA 18103               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
BALLARD MEDICAL PRODUCTS          510(k) NO: K000495(TRADITIONAL)
ATTN: E. MARTIN  CHAMBERLAIN      PHONE NO : 801-572-6800
12050 LONE PEAK PKWY.             SE DECISION MADE: 28-MAR-00
DRAPER, UT 84020                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BARCOMED 5MP1H
BARCO NV                          510(k) NO: K000014(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 14-MAR-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARCOMED 5MP2
BARCO NV                          510(k) NO: K000016(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 14-MAR-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MFCD 118
BARCO NV                          510(k) NO: K000291(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 27-MAR-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
BARCO NV                          510(k) NO: K000292(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 29-MAR-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
BARCO NV                          510(k) NO: K000293(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 29-MAR-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MFCD 120
BARCO NV                          510(k) NO: K000294(TRADITIONAL)
ATTN: FRANK  FERGUSON             PHONE NO : 858-587-1147
P.O. BOX 12038                    SE DECISION MADE: 27-MAR-00
LA JOLLA, CA 92039-2038           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LE
BAUSCH & LOMB, INC.               510(k) NO: K994125(TRADITIONAL)
ATTN: GLENN A DAVIES              PHONE NO : 716-338-8215
1400 NORTH GOODMAN STREET         SE DECISION MADE: 03-MAR-00
ROCHESTER, NY 14692-0450          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUER ACCESS UNIVERSAL VIAL ADAPTER
BAXTER HEALTHCARE CORP.           510(k) NO: K000657(TRADITIONAL)
ATTN: MARY ELLEN  SNYDER          PHONE NO : 847-270-4644
RT. 120 AND WILSON ROAD           SE DECISION MADE: 08-MAR-00
ROUND LAKE, IL 60073-0490         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
BD/PREEFIL                        510(k) NO: K982558(TRADITIONAL)
ATTN: GREG  MORGAN                PHONE NO : 201-847-4344
1 BECTON DR. MC 226               SE DECISION MADE: 08-MAR-00
FRANKLIN LAKES, NJ 07417          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ISOSEED PD-103
BEBIG ISOTOPENTECHNIK GMBH        510(k) NO: K993552(TRADITIONAL)
ATTN: SVEN  LANGER                PHONE NO : 493 094 70840 X 76
ROBERT-ROSSLE/STR.10              SE DECISION MADE: 31-MAR-00
BERLIN-BUCH, GERMANY 13125        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
BECKMAN COULTER, INC.             510(k) NO: K000716(SPECIAL)
ATTN: ANGELA M BYLAND             PHONE NO : 612-368-1615
1000 LAKE HAZELTINE DR.           SE DECISION MADE: 20-MAR-00
CHASKA, MN 55318-1084             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
BECKMAN COULTER, INC.             510(k) NO: K994278(TRADITIONAL)
ATTN: JILL  KULL                  PHONE NO : 858-621-4584
7330 CARROLL ROAD                 SE DECISION MADE: 28-MAR-00
SAD DIEGO, CA 92196-9006          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT
BERNARD B. FRESCO                 510(k) NO: K991840(TRADITIONAL)
ATTN: BERNARD B FRESCO            PHONE NO : 416 922 2707
40 SAINT CLAIR AVE EAST 303       SE DECISION MADE: 20-MAR-00
TORONTO, ONTARIO, CANADA M4T 1M9  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVE
BEST MFG. CO.                     510(k) NO: K993805(TRADITIONAL)
ATTN: DAVID C YOUNG               PHONE NO : 706-862-2302
579 EDISON STREET                 SE DECISION MADE: 10-MAR-00
MENLO, GA 30731                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYLASINE
BIOMATRIX, INC.                   510(k) NO: K993362(TRADITIONAL)
ATTN: MARIO J RERES               PHONE NO : 201-945-9550
65 RAILROAD AVE.                  SE DECISION MADE: 13-MAR-00
RIDGEFIELD, NJ 07657              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYLASHIELD CL
BIOMATRIX, INC.                   510(k) NO: K994170(TRADITIONAL)
ATTN: NADINE M QASHU              PHONE NO : 201-945-9550
65 RAILROAD AVE.                  SE DECISION MADE: 02-MAR-00
RIDGEFIELD, NJ 07657              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
BIOMET, INC.                      510(k) NO: K000538(SPECIAL)
ATTN: DALENE T BINKLEY            PHONE NO : 219-372-1612
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 15-MAR-00
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580

DEVICE: SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 4
BIONX IMPLANTS, LTD.              510(k) NO: K000616(SPECIAL)
ATTN: TUIJA  ANNALA               PHONE NO : 358 331 65600
HERMIANKATU 6-8 L                 SE DECISION MADE: 23-MAR-00
TAMPERE, FINLAND FIN-33720        510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
BIOSITE DIAGNOSTICS               510(k) NO: K000231(TRADITIONAL)
ATTN: JOHN F BRUNI                PHONE NO : 619-455-4808
11030 ROSELLE ST.                 SE DECISION MADE: 02-MAR-00
SAN DIEGO, CA 92121               510(k) STATEMENT

DEVICE: BLADEWORKS MICROKERATOME BLADE
BLADE WORKS INC.                  510(k) NO: K993225(TRADITIONAL)
ATTN: GARY S MOCNIK               PHONE NO : 949-363-2953
107 SOUTH COVINGTON STREET        SE DECISION MADE: 20-MAR-00
HILLSBORO, TX 76445               510(k) STATEMENT

DEVICE: BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT
BODYSTAT LTD.                     510(k) NO: K994242(TRADITIONAL)
ATTN: I. J MEEUWSEN               PHONE NO : 440 162 4629571
PO BOX 50                         SE DECISION MADE: 15-MAR-00
DOUGLAS ISLE OF MAN IM99 IDDQ     510(k) STATEMENT
BRITISH ISLES, BRAZIL

DEVICE: ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
BONART CO. LTD.                   510(k) NO: K994203(TRADITIONAL)
ATTN: BANKSON  TSAI               PHONE NO : 886 222 983980
RM. 405, NO.3 WUCHUAN 1ST ROAD    SE DECISION MADE: 06-MAR-00
HSINCHUANG, TAIPEI, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ART-P3, MODEL P3-1-ART-A1
BONART CO. LTD.                   510(k) NO: K994299(TRADITIONAL)
ATTN: BANKSON  TSAI               PHONE NO : 886 222 983980
RM. 405, NO.3 WUCHUAN 1ST ROAD    SE DECISION MADE: 06-MAR-00
HSINCHUANG, TAIPEI, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; IN
BOSTON SCIENTIFIC CORP.           510(k) NO: K000397(SPECIAL)
ATTN: ABBY  LIPMAN                PHONE NO : 508-650-8249
ONE BOSTON SCIENTIFIC PLACE       SE DECISION MADE: 07-MAR-00
NATICK, MA 01760                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORP.           510(k) NO: K993303(TRADITIONAL)
ATTN: TERRY A MCGOVERN            PHONE NO : 508-652-5439
ONE BOSTON SCIENTIFIC PLACE       SE DECISION MADE: 23-MAR-00
NATICK, MA 01760-1537             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
BOSTON SCIENTIFIC, TARGET         510(k) NO: K993292(TRADITIONAL)
ATTN: GOWAN  LEE                  PHONE NO : 800-662-2415
47900 BAYSIDE PARKWAY             SE DECISION MADE: 23-MAR-00
FREMONT, CA 94538                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
BRAHMS DIAGNOSTICA, LLC           510(k) NO: K000286(TRADITIONAL)
ATTN: H. LEE  HERRON              PHONE NO : 770-449-7738
29 SOUTH PEACHTREE STREET         SE DECISION MADE: 17-MAR-00
NORCROSS, GA 30071                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
BRAHMS DIAGNOSTICA, LLC           510(k) NO: K000287(TRADITIONAL)
ATTN: H. LEE  HERRON              PHONE NO : 770-449-7738
29 SOUTH PEACHTREE STREET         SE DECISION MADE: 17-MAR-00
NORCROSS, GA 30071                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEMOTHERM COLORECTAL STENT
C.R. BARD, INC.                   510(k) NO: K990504(TRADITIONAL)
ATTN: MARION  GORDON              PHONE NO : 978-262-4867
129 CONCORD RD., BLDG. #3         SE DECISION MADE: 16-MAR-00
BILLERICA, MA 01821               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARD ENDOSCOPIC SUTURING SYSTEM
C.R. BARD, INC.                   510(k) NO: K994290(TRADITIONAL)
ATTN: BETH A ZIS                  PHONE NO : 978-262-4866
129 CONCORD RD., BLDG. 3          SE DECISION MADE: 20-MAR-00
BILLERICA, MA 01821-7031          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOOTHBRUSH WASH
CAL HUECH INC.                    510(k) NO: K994144(TRADITIONAL)
ATTN: CHERYL A LITTLE             PHONE NO : 912-953-5771
105 SETTLERS TRAIL                SE DECISION MADE: 02-MAR-00
WARNER ROBINS, GA 31088           510(k) STATEMENT

DEVICE: CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH
CARDIAC PATHWAYS CORP.            510(k) NO: K992912(TRADITIONAL)
ATTN: DEBRA S ECHT                PHONE NO : 408-737-0505
995 BENECIA AVE.                  SE DECISION MADE: 08-MAR-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3
CARDIOTRON, LLC                   510(k) NO: K992703(TRADITIONAL)
ATTN: WILLIAM D HARE              PHONE NO : 202-783-5070
601 13TH STREET, N.W.             SE DECISION MADE: 21-MAR-00
SUITE 901 SOUTH                   510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005

DEVICE: (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
CARDIOVASCULAR DIAGNOSTICS, INC.  510(k) NO: K994194(TRADITIONAL)
ATTN: PETER  SCOTT                PHONE NO : 800-849-7070
5301 DEPARTURE DR.                SE DECISION MADE: 28-MAR-00
RALEIGH, NC 27616                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IOLMASTER
CARL ZEISS, INC.                  510(k) NO: K993357(TRADITIONAL)
ATTN: SCOTT A MARGOLIN            PHONE NO : 914-681-7880
ONE ZEISS DR.                     SE DECISION MADE: 20-MAR-00
THORNWOOD, NY 10594               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OOCYTE ASPIRATION NEEDLE
CASMED UK                         510(k) NO: K991271(TRADITIONAL)
ATTN: DEBORAH  CASTLE             PHONE NO : 017 373 79898
39 NORK WAY BANSTEAD              SE DECISION MADE: 08-MAR-00
SURREY, UNITED KINGDOM SM7 1PB    510(k) STATEMENT

 
DEVICE: CBYON SURGICAL OPERATING SYSTEM (SOS)
CBYON, INC.                       510(k) NO: K000171(TRADITIONAL)
ATTN: RORY  RANDALL               PHONE NO : 650-842-1800
2275 E. BAYSHORE RD               SE DECISION MADE: 13-MAR-00
SUITE 101                         510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94303

DEVICE: COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
COBE CARDIOVASCULAR, INC.         510(k) NO: K994389(TRADITIONAL)
ATTN: LYNNE  LEONARD              PHONE NO : 303-467-6586
14401 WEST 65TH WAY               SE DECISION MADE: 27-MAR-00
ARVADA, CO 80004                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
COGENT DIAGNOTICS LTD.            510(k) NO: K993557(TRADITIONAL)
ATTN: DANIELLE M KNIGHT           PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK            SE DECISION MADE: 03-MAR-00
BUSH LOAN                         510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL

DEVICE: COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
COHERENT, INC.                    510(k) NO: K000498(SPECIAL)
ATTN: EDWARD C YU                 PHONE NO : 408-764-3912
2400 CONDENSA ST.                 SE DECISION MADE: 13-MAR-00
SANTA CLARA, CA 95051-0901        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARAPOST FIBER WHITE
COLTENE/WHALEDENT INC.            510(k) NO: K000311(TRADITIONAL)
ATTN: H.J.  VOGELSTEIN            PHONE NO : 201-512-8000
750 CORPORATE DR.                 SE DECISION MADE: 14-MAR-00
MAHWAH, NJ 07430-2009             510(k) STATEMENT

DEVICE: COMPUMEDICS E-SERIES EEG SYSTEM
COMPUMEDICS NEURO SCIENCE PTY LTD.510(k) NO: K000068(TRADITIONAL)
ATTN: CONSTANCE G BUNDY           PHONE NO : 612-574-1976
6470 RIVERVIEW TERRACE            SE DECISION MADE: 13-MAR-00
MINNEAPOLIS, MN 55432             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ
COOK UROLOGICAL, INC.             510(k) NO: K994417(TRADITIONAL)
ATTN: DEBBIE  SCHMITT             PHONE NO : 812-829-4891
1100 WEST MORGAN ST.              SE DECISION MADE: 01-MAR-00
P.O. BOX 227                      510(k) SUMMARY AVAILABLE FROM FDA
SPENCER, IN 47460

DEVICE: FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVI
COOPERVISION, INC.                510(k) NO: K000384(SPECIAL)
ATTN: BONNIE  TSYMBAL             PHONE NO : 716-264-3210
711 NORTH RD.                     SE DECISION MADE: 06-MAR-00
SCOTTSVILLE, NY 14546             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
CORDIS CORP.                      510(k) NO: K000564(SPECIAL)
ATTN: KAREN  WILK                 PHONE NO : 908-412-7257
7 POWDERHORN DRIVE                SE DECISION MADE: 23-MAR-00
WARREN, NJ 07059                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ENVOY AND VISTA BRITE TIP
CORDIS CORP.                      510(k) NO: K000715(SPECIAL)
ATTN: DENNIS S GRIFFIN            PHONE NO : 305-824-5283
14201 N.W. 60TH AVE.              SE DECISION MADE: 31-MAR-00
MIAMI LAKES, FL 33014             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROD TO ROD CROSS BRACES
CORIN LTD.                        510(k) NO: K000634(SPECIAL)
ATTN: MEL  LONGHURST              PHONE NO : 011 441 28565966
THE CORINIUM CENTER               SE DECISION MADE: 10-MAR-00
CIRENCESTER, UNITED KINGDOM GL71YJ510(k) STATEMENT

DEVICE: THE LIGAMENT ANCHOR SOFT SCREW
CORIN U.S.A.                      510(k) NO: K994152(TRADITIONAL)
ATTN: CRAIG  CORRANCE             PHONE NO : 813-979-0042
10500 UNIVERSITY CENTER DR.,      SE DECISION MADE: 06-MAR-00
SUITE 190                         510(k) SUMMARY AVAILABLE FROM FDA
TAMPA, FL 33612

DEVICE: CORTEK CYSTOSCOPE
CORTEK ENDOSCOPY, INC.            510(k) NO: K000197(TRADITIONAL)
ATTN: CORNEL M TOPALA             PHONE NO : 847-963-8487
501 W. COLFAX, SUITE B            SE DECISION MADE: 03-MAR-00
PALATINE, IL 60067                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORTEK URETHEROSCOPE
CORTEK ENDOSCOPY, INC.            510(k) NO: K000200(TRADITIONAL)
ATTN: CORNEL M TOPALA             PHONE NO : 847-963-8487
501 W. COLFAX, SUITE B            SE DECISION MADE: 03-MAR-00
PALATINE, IL 60067                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORTEK LAPAROSCOPES
CORTEK ENDOSCOPY, INC.            510(k) NO: K000202(TRADITIONAL)
ATTN: CORNEL M TOPALA             PHONE NO : 847-963-8487
501 W. COLFAX, SUITE B            SE DECISION MADE: 31-MAR-00
PALATINE, IL 60067                510(k) STATEMENT

DEVICE: MPT 24 AND VITAL VIEW 24
CRITICARE SYSTEMS, INC.           510(k) NO: K000276(SPECIAL)
ATTN: ALEX  KAPLAN                PHONE NO : 262-798-8282
20925 CROSSROADS CIRCLE           SE DECISION MADE: 01-MAR-00
WAUKESHA, WI 53186                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CYNOSURE PHOTOGENICA VLS-STAR
CYNOSURE, INC.                    510(k) NO: K000490(SPECIAL)
ATTN: GEORGE  CHO                 PHONE NO : 978-256-4200
10 ELIZABETH DR.                  SE DECISION MADE: 13-MAR-00
CHELMSFORD, MA 01824              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION SPECIAL PROTEIN CALIBRATOR
DADE BEHRING, INC.                510(k) NO: K994291(TRADITIONAL)
ATTN: RICHARD M VAUGHT            PHONE NO : 302-631-6567
P.O. BOX 6101                     SE DECISION MADE: 01-MAR-00
ROUTE 896, GLASGOW BLDG. 500      510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101

 
DEVICE: DIMENSION C4 FLEX REAGENT CARTRIDGE
DADE BEHRING, INC.                510(k) NO: K994293(TRADITIONAL)
ATTN: RICHARD M VAUGHT            PHONE NO : 302-631-6567
P.O. BOX 6101                     SE DECISION MADE: 01-MAR-00
ROUTE 896, GLASGOW BLDG. 500      510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101

DEVICE: DIMENSION C3 FLEX REAGENT CARTRIDGE
DADE BEHRING, INC.                510(k) NO: K994296(TRADITIONAL)
ATTN: RICHARD M VAUGHT            PHONE NO : 302-631-6567
P.O. BOX 6101                     SE DECISION MADE: 01-MAR-00
GLASGOW BLDG. 500                 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101

DEVICE: FIBRINOGEN CALIBRATOR KIT
DADE BEHRING, INC.                510(k) NO: K994341(TRADITIONAL)
ATTN: REBECCA S AYASH             PHONE NO : 302-631-6276
P.O. BOX 6101                     SE DECISION MADE: 03-MAR-00
GLASGOW BLDG. 500                 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101

DEVICE: DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
DAKO CORP.                        510(k) NO: K993957(TRADITIONAL)
ATTN: GRETCHEN M MURRAY           PHONE NO : 805-566-6655
6392 VIA REAL                     SE DECISION MADE: 03-MAR-00
CARPINTERIA, CA 93013             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES
DATASCOPE CORP.                   510(k) NO: K994157(TRADITIONAL)
ATTN: WHITNEY  TORNING            PHONE NO : 973-244-6136
15 LAW DR.                        SE DECISION MADE: 13-MAR-00
FAIRFIELD, NJ 07004-3206          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
DATEX-OHMEDA, INC.                510(k) NO: K993512(SPECIAL)
ATTN: DALE  THANIG                PHONE NO : 303-666-7001
1315 WEST CENTURY DR.             SE DECISION MADE: 31-MAR-00
LOUISVILLE, CO 80027              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DATEX-OHMEDA TONOMETRY MODULE M-TONO
DATEX-OHMEDA, INC.                510(k) NO: K993656(TRADITIONAL)
ATTN: JOEL C KENT                 PHONE NO : 800-635-6099
3 HIGHWOOD DR.                    SE DECISION MADE: 15-MAR-00
TEWKSBURY, MA 01876               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
DENTSPLY INTL.                    510(k) NO: K000169(TRADITIONAL)
ATTN: P. JEFFERY  LEHN            PHONE NO : 717-845-7511
570 WEST COLLEGE AVE.             SE DECISION MADE: 24-MAR-00
YORK, PA 17405                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORT
DENTSPLY INTL.                    510(k) NO: K994285(TRADITIONAL)
ATTN: WILLIAM T COUSINS           PHONE NO : 847-640-4924
901 WEST OAKTON ST.               SE DECISION MADE: 14-MAR-00
DES PLAINES, IL 60018-1884        510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PINNACLE ACETABULAR SYSTEM
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K000306(SPECIAL)
ATTN: LYNNETTE  WHITAKER          PHONE NO : 219-371-4903
700 ORTHOPAEDIC DR.               SE DECISION MADE: 23-MAR-00
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
DEPUY ORTHOPAEDICS, INC.          510(k) NO: K000575(TRADITIONAL)
ATTN: MARCIA J ARENTZ             PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR.               SE DECISION MADE: 10-MAR-00
WARSAW, IN 46581-0988             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REFLEX TREATMENT SYSTEM
DESCHUTES MEDICAL PRODUCTS, INC.  510(k) NO: K994079(TRADITIONAL)
ATTN: DENISE  BESTWICK            PHONE NO : 541-385-0350
1011 S.W. EMKAY DR., SUITE 104    SE DECISION MADE: 01-MAR-00
BEND, OR 97702                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # L
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K000005(TRADITIONAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 03-MAR-00
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
DIAGNOSTIC PRODUCTS CORP.         510(k)NO:K000012(TRADITIONAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 03-MAR-00
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UCLA/UNIVERSAL ABUTMENT
DIAMODENT, INC.                   510(k) NO: K993129(TRADITIONAL)
ATTN: JEFF  RASSOLI               PHONE NO : 714-637-7483
695 SOUTH MORNINGSTAR DRIVE       SE DECISION MADE: 28-MAR-00
ANAHEIM, CA 92808                 510(k) STATEMENT

DEVICE: NARKOMED 6000
DRAEGER MEDICAL, INC.             510(k) NO: K993826(TRADITIONAL)
ATTN: GALE E WINARSKY             PHONE NO : 215-721-5400
3135 QUARRY RD.                   SE DECISION MADE: 23-MAR-00
TELFORD, PA 18969                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1
E. BENSON HOOD LAB, INC.          510(k) NO: K000154(TRADITIONAL)
ATTN: ANTHONY M SACCHETTI         PHONE NO : 781-826-7573
575 WASHINGTON ST.                SE DECISION MADE: 29-MAR-00
PEMBROKE, MA 02359                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
EBI, L.P.                         510(k) NO: K000513(SPECIAL)
ATTN: JON  CAPAROTTA              PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 07-MAR-00
PARSIPPANY, NJ 07054-1079         510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CODE AC:  ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-A
ELGEMS, LTD.                      510(k) NO: K994167(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 485 63660
P.O. BOX 170                      SE DECISION MADE: 07-MAR-00
TIRAT HACARMEL, ISRAEL 30200      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ISOBAR SPINAL SYSTEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K000425(SPECIAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 07-MAR-00
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERICHEK TOTAL CHLORINE REAGENT STRIPS
ENVIRONMENTAL TEST SYSTEMS, INC.  510(k) NO: K994226(TRADITIONAL)
ATTN: DAVID A MORRIS              PHONE NO : 219-262-2060
23575 COUNTY RD., #106            SE DECISION MADE: 22-MAR-00
ELKHART, IN 46514                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVI
ENVITEC-WISMAR GMBH               510(k) NO: K992215(TRADITIONAL)
ATTN: STEPHEN H GORSKI            PHONE NO : 414-594-2114
N8259 COTTAGE DRIVE               SE DECISION MADE: 29-MAR-00
FOND DU LAC, WI 54937             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EP MEDSYSTEMS, EP-WORKMATE
EP MEDSYSTEMS, INC.               510(k) NO: K994011(SPECIAL)
ATTN: JOSEPH C GRIFFIN III        PHONE NO : 856-753-8533
100 STIERLI CT., SUITE 107        SE DECISION MADE: 23-MAR-00
MOUNT ARLINGTON, NJ 07856         510(k) STATEMENT

DEVICE: ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS
ERECXEL ENTERPRISES               510(k) NO: K993343(TRADITIONAL)
ATTN: PACIFICO R BURGOS           PHONE NO : 323-340-8268
3249 SAN FEMANDO RD.              SE DECISION MADE: 20-MAR-00
LOS ANGELES, CA 90065             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPIRO PRO
ERICH JAEGER GMBH                 510(k) NO: K000648(SPECIAL)
ATTN: LARRY  MURDOCK              PHONE NO : 714-283-2228
22705 SAVI RANCH PARKWAY          SE DECISION MADE: 29-MAR-00
YORBA LINDA, CA 92887-4645        510(k) STATEMENT

DEVICE: DIMENSION GARANT L, DIMENSION GARANT L QUICK
ESPE DENTAL AG                    510(k) NO: K000588(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 011 498 1527001395
ESPE PLATZ                        SE DECISION MADE: 30-MAR-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIMENSION PENTA H, DIMENSION PENTA H QUICK
ESPE DENTAL AG                    510(k) NO: K000591(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 011 498 1527001395
ESPE PLATZ                        SE DECISION MADE: 30-MAR-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODE
ETHICON ENDO-SURGERY, INC.        510(k) NO: K994280(TRADITIONAL)
ATTN: RUTH ANN  WOOD              PHONE NO : 513-337-3468
4545 CREEK RD.                    SE DECISION MADE: 17-MAR-00
CINCINNATI, OH 45242-2839         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BITX PROBES
EVEREST MEDICAL CORP.             510(k) NO: K993412(TRADITIONAL)
ATTN: FREDERICK G MADES           PHONE NO : 612-473-6262
13755 FIRST AVE. NORTH, #500      SE DECISION MADE: 31-MAR-00
MINNEAPOLIS, MN 55441-5454        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
FERRARIS MEDICAL, INC.            510(k) NO: K993199(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 28-MAR-00
WASHINGTON, DC                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER
FONAR CORP.                       510(k) NO: K994287(TRADITIONAL)
ATTN: LUCIANO  BONANNI            PHONE NO : 516-694-2929
110 MARCUS DR.                    SE DECISION MADE: 16-MAR-00
MELVILLE, NY 11747                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS 2008K
FRESENIUS MEDICAL CARE            510(k) NO: K994267(TRADITIONAL)
ATTN: ARTHUR  EILINSFELD          PHONE NO : 781-402-9068
TWO LEDGEMONT CENTER              SE DECISION MADE: 16-MAR-00
95 HAYDEN AVENUE                  510(k) SUMMARY AVAILABLE FROM FDA
LEXINGTON, MA 02420

DEVICE: FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING;
FRIADENT GMBH                     510(k) NO: K994376(TRADITIONAL)
ATTN: CAROL  PATTERSON            PHONE NO : 949-462-0900
21911 ERIE LANE                   SE DECISION MADE: 24-MAR-00
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLAR 7/8000
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K993757(TRADITIONAL)
ATTN: KAREN  WEBB                 PHONE NO : 414-362-3329
8200 WEST TOWER AVE.              SE DECISION MADE: 23-MAR-00
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K994430(TRADITIONAL)
ATTN: KAREN  WEBB                 PHONE NO : 414-362-3329
8200 WEST TOWER AVE.              SE DECISION MADE: 28-MAR-00
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTRICULAR ANALYSIS TOOLKIT OPTION
GE MEDICAL SYSTEM                 510(k) NO: K000315(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 414-544-3894
P.O. BOX 414                      SE DECISION MADE: 27-MAR-00
W-709                             510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53201

 
DEVICE: GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPL
GE MEDICAL SYSTEMS, INC.          510(k) NO: K000695(TRADITIONAL)
ATTN: ALLEN  SCHUH                PHONE NO : 414-647-4385
P.O. BOX 414                      SE DECISION MADE: 16-MAR-00
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HI
GENZYME CORP.                     510(k) NO: K000239(TRADITIONAL)
ATTN: BARBARA  PIZZA              PHONE NO : 617-252-7953
ONE KENDALL SQUARE                SE DECISION MADE: 21-MAR-00
CAMBRIDGE, MA 02139-1562          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
GENZYME CORP.                     510(k) NO: K994328(TRADITIONAL)
ATTN: JOHN A DELUCIA              PHONE NO : 617-374-7266
ONE KENDALL SQUARE                SE DECISION MADE: 02-MAR-00
CAMBRIDGE, MA 02139-1562          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
GRASS INSTRUMENT CO.              510(k) NO: K994142(TRADITIONAL)
ATTN: STEPHEN E JOHNSON           PHONE NO : 781-848-2970
570 LIBERTY ST.                   SE DECISION MADE: 06-MAR-00
BRAINTREE, MA 02185               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 5F GUIDING CATHETER
GUIDANT CORP.                     510(k) NO: K000598(SPECIAL)
ATTN: MARGARET  ANDERSON          PHONE NO : 408-845-3995
3200 LAKESIDE DR.                 SE DECISION MADE: 24-MAR-00
SANTA CLARA, CA 95054             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HARDYDISK TICARILLIN 75MCG
HARDY DIAGNOSTICS                 510(k) NO: K000175(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 02-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, CARBENICILLIN, 100MCG
HARDY DIAGNOSTICS                 510(k) NO: K000181(TRADITIONAL)
ATTN: MELISSA M TRAY              PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 02-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, KANAMYCIN, 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K000203(TRADITIONAL)
ATTN: MELISSA  TRAYLOR            PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 21-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, CIPROFLOXACIN, 5MCG
HARDY DIAGNOSTICS                 510(k) NO: K000258(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 21-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

 
DEVICE: HARDYDISK, CEFTAZIDIME, 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K000259(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 21-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDY DISK, PENICILLIN, 10 UNITS
HARDY DIAGNOSTICS                 510(k) NO: K000302(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 24-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, TETRACYCLINE 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K000304(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 29-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK, CEFOXITIN, 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K000305(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 31-MAR-00
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
HITACHI MEDICAL CORP. OF AMERICA  510(k) NO: K994026(TRADITIONAL)
ATTN: CHARLES F HOTTINGER         PHONE NO : 408-741-1006
19030 PORTOS DRIVE                SE DECISION MADE: 29-MAR-00
SARATOGA, CA 95070                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIRIS II
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K994378(TRADITIONAL)
ATTN: DOUGLAS J THISTLETHWAITE    PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 07-MAR-00
TWINSBURG, OH 44087-2371          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE HOMMED SENTRY, MODEL 1 SENTRY
HOMMED LLC                        510(k) NO: K993938(TRADITIONAL)
ATTN: HERSCHEL  PEDDICORD         PHONE NO : 414-783-5440
19275 WEST CAPITOL DRIVE          SE DECISION MADE: 15-MAR-00
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
BROOKFIELD, WI 53045

DEVICE: DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
HOWMEDICA OSTEONICS CORP.         510(k) NO: K000091(TRADITIONAL)
ATTN: TERRY SHERIDAN  POWELL      PHONE NO : 201-934-4375
59 ROUTE 17                       SE DECISION MADE: 10-MAR-00
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K994128(TRADITIONAL)
ATTN: TERRY  SHERIDAN POWELL      PHONE NO : 201-934-4375
59 ROUTE 17                       SE DECISION MADE: 06-MAR-00
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
HOWMEDICA OSTEONICS CORP.         510(k) NO: K994207(TRADITIONAL)
ATTN: MARY-CATHERINE  DILLON      PHONE NO : 201-760-8117
59 ROUTE 17                       SE DECISION MADE: 13-MAR-00
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CENTAUR SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K994347(TRADITIONAL)
ATTN: MARY-CATHERINE  DILLON      PHONE NO : 201-760-8117
59 ROUTE 17                       SE DECISION MADE: 15-MAR-00
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K994366(TRADITIONAL)
ATTN: NANCY J RIEDER              PHONE NO : 201-507-7956
359 VETERANS BLVD.                SE DECISION MADE: 16-MAR-00
RUTHERFORD, NJ 07070-2584         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
HUDSON RESPIRATORY CARE, INC.     510(k) NO: K994352(TRADITIONAL)
ATTN: JEANNIE  DENNING            PHONE NO : 909-676-5611
27711 DIAZ RD.                    SE DECISION MADE: 22-MAR-00
TEMECULA, CA 92589-9020           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROCISION DEBDRIDEMENT SYSTEM
HYDROCISION, INC.                 510(k) NO: K991383(TRADITIONAL)
ATTN: DEBBIE  IAMPIETRO           PHONE NO : 508-435-9893
7 TIFFANY                         SE DECISION MADE: 31-MAR-00
HOPKINTON, MA 01748               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOAKER CATHETER
I-FLOW CORP.                      510(k) NO: K994374(TRADITIONAL)
ATTN: STANLEY E FRY               PHONE NO : 949-206-2700
20202 WINDROW DR.                 SE DECISION MADE: 03-MAR-00
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODEL 445SI-64E QUADRATURE WRIST COIL
IGC-MEDICAL ADVANCES, INC.        510(k) NO: K000589(TRADITIONAL)
ATTN: THOMAS E TYNES              PHONE NO : 414-258-3808
10437 INNOVATION DRIVE            SE DECISION MADE: 14-MAR-00
MILWAUKEE, WI 53226               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-
IMATRON, INC.                     510(k) NO: K000359(TRADITIONAL)
ATTN: J.A.  CODUTO                PHONE NO : 503-638-5500
389 OYSTER POINT BLVD.            SE DECISION MADE: 17-MAR-00
SOUTH SAN FRANCISCO, CA 94080     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MLC FIT
IMPAC MEDICAL SYSTEMS, INC.       510(k) NO: K991133(TRADITIONAL)
ATTN: THOMAS  FARIS               PHONE NO : 650-254-4700
215 CASTRO ST.                    SE DECISION MADE: 27-MAR-00
MOUNTAIN VIEW, CA 94041           510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: I-PLANT, MODEL 3500
IMPLANT SCIENCES CORP.            510(k) NO: K994317(TRADITIONAL)
ATTN: HOWARD L SCHRAYER           PHONE NO : 609-924-9510
107 AUDUBON ROAD, #5              SE DECISION MADE: 21-MAR-00
WAKEFIELD, MA 01880-1246          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZ
IMPLEX CORP.                      510(k) NO: K990330(TRADITIONAL)
ATTN: ROBERT  POGGIE              PHONE NO : 201-818-1800
80 COMMERCE DR.                   SE DECISION MADE: 01-MAR-00
ALLENDALE, NJ 07401-1600          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVIGRA MALE LATEX CONDOM GREEN COLORED AND MINT FLAVORED
INDUS MEDICARE LTD.               510(k) NO: K000038(ABBREVIATED)
ATTN: P.K.  REDDY                 PHONE NO : 914 077 60241
144, S.P. RD., BEGUMPET           SE DECISION MADE: 21-MAR-00
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT

DEVICE: INVIGRA MALE LATEX CONDOM YELLOW COLORED AND BANANA FLAVORED
INDUS MEDICARE LTD.               510(k) NO: K000039(ABBREVIATED)
ATTN: P.K.  REDDY                 PHONE NO : 914 077 60241
144, S.P. RD., BEGUMPET           SE DECISION MADE: 21-MAR-00
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT

DEVICE: INVIGRA MALE LATEX CONDOM BLUE COLORED AND VANILLA FLAVORED
INDUS MEDICARE LTD.               510(k) NO: K000040(ABBREVIATED)
ATTN: P.K.  REDDY                 PHONE NO : 914 077 60241
144, S.P. RD., BEGUMPET           SE DECISION MADE: 21-MAR-00
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT

DEVICE: RTLX
INFIMED, INC.                     510(k) NO: K992392(TRADITIONAL)
ATTN: RALPH  FLATAU               PHONE NO : 315-453-4545
121 METROPOLITAN DR.              SE DECISION MADE: 31-MAR-00
LIVERPOOL, NY 13088               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACL 9000 SYSTEM
INSTRUMENTATION LABORATORY CO.    510(k) NO: K000053(TRADITIONAL)
ATTN: CAROL  MARBLE               PHONE NO : 781-861-4467
113 HARTWELL AVE.                 SE DECISION MADE: 15-MAR-00
LEXINGTON, MA 02421               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
INTERNATIONAL DISTRIBUTORS OF ELEC510(k) NO: K994254(TRADITIONAL)
ATTN: DONNA  WARD                 PHONE NO : 800-947-6334
4814 EAST SECOND STREET           SE DECISION MADE: 14-MAR-00
BENICIA, CA 94510                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K000309(TRADITIONAL)
ATTN: ROBERTA L JOHNSON           PHONE NO : 800-437-5706
2511 DAIMLER ST.                  SE DECISION MADE: 13-MAR-00
SANTA ANA, CA 92705               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
JAWON MEDICAL CO., LTD.           510(k) NO: K000675(TRADITIONAL)
ATTN: ROBERT D WAXHAM             PHONE NO : 757-365-0978
222 INSTITUTE ST.                 SE DECISION MADE: 14-MAR-00
SMITHFIELD, VA 23430              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BUILD-IT FR
JENERIC/PENTRON, INC.             510(k) NO: K000211(TRADITIONAL)
ATTN: ANNMARIE  TENERO            PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD.    SE DECISION MADE: 17-MAR-00
P.O. BOX 724                      510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724

DEVICE: BOND 1 C & B
JENERIC/PENTRON, INC.             510(k) NO: K994359(TRADITIONAL)
ATTN: ANNMARIE  TENERO            PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD.    SE DECISION MADE: 21-MAR-00
P.O. BOX 724                      510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724

DEVICE: CODMAN ETHISORB DURA PATCH
JOHNSON & JOHNSON PROFESSIONALS, I510(k) NO: K991413(TRADITIONAL)
ATTN: DEANA  BOUSHELL             PHONE NO : 508-828-3107
325 PARAMOUNT DR.                 SE DECISION MADE: 13-MAR-00
RAYNHAM, MA 02767                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
KAOHSIUNG BROTHERS PRODUCTS CORP. 510(k) NO: K000058(TRADITIONAL)
ATTN: STONE  CHEN                 PHONE NO : 886 075 612201
23 KOOSHAN 3RD RD.                SE DECISION MADE: 10-MAR-00
KAOHSIUNG, CHINA (TAIWAN) 80414   510(k) STATEMENT

DEVICE: KSEA SCB-RUI
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K994348(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 03-MAR-00
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KAWASUMI LABORATORIES PHILEBOTOMY SET
KAWASUMI LABORATORIES CO., LTD.   510(k) NO: K994323(TRADITIONAL)
ATTN: DONALD R STONE              PHONE NO : 202-496-7620
1900 K STREET N.W.                SE DECISION MADE: 08-MAR-00
WASHINGTON, DC 20006              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
KENDALL CO.                       510(k) NO: K000087(TRADITIONAL)
ATTN: REGINA  YEH                 PHONE NO : 508-261-8000
15 HAMPSHIRE STREET               SE DECISION MADE: 17-MAR-00
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
LABTICIAN OPHTHALMICS, INC.       510(k) NO: K000544(TRADITIONAL)
ATTN: R. DAVID  SCULATI           PHONE NO : 905 829 0055
2140 WINSTON PARK DR., UNIT 6     SE DECISION MADE: 09-MAR-00
OAKVILLE, ONTARIO, CANADA L6H 5V5 510(k) STATEMENT

 
DEVICE: MODIFIED HYDROPHILIC COATED GUIDEWIRE
LAKE REGION MFG., INC.            510(k) NO: K000011(SPECIAL)
ATTN: JIM  KLOSTERMAN             PHONE NO : 612-448-5111
340 LAKE HAZELTINE DR.            SE DECISION MADE: 01-MAR-00
CHASKA, MN 55318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORION SERIES SURGICAL  LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG
LASERSCOPE                        510(k) NO: K990718(TRADITIONAL)
ATTN: PAUL H HARDIMAN             PHONE NO : 800-243-9384
3052 ORCHARD DR.                  SE DECISION MADE: 08-MAR-00
SAN JOSE, CA 95134-2011           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
LIFECORE BIOMEDICAL, INC.         510(k) NO: K993894(TRADITIONAL)
ATTN: CAROLYN  ANDERSON           PHONE NO : 612-368-6324
3515 LYMAN BLVD.                  SE DECISION MADE: 08-MAR-00
CHASKA, MN 55318                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
MACHIDA ENDOSCOPE CO., LTD.       510(k) NO: K993568(TRADITIONAL)
ATTN: GENICHI  KANAI              PHONE NO : 339 462 621
13-8, HONKOMAGOME 6-CHOME,        SE DECISION MADE: 13-MAR-00
BUNKYO-KU                         510(k) SUMMARY AVAILABLE FROM FDA
TOKYO, JAPAN

DEVICE: UBAS
MARUKIN DIAGNOSTICS               510(k) NO: K993941(TRADITIONAL)
ATTN: GREG  HOLLAND               PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 02-MAR-00
IRVINE, CA 92606                  510(k) STATEMENT

DEVICE: ENDOSCOPIC ANTI FOG DEVICE
MECTRA LABS, INC.                 510(k) NO: K993604(TRADITIONAL)
ATTN: CHARLES E ALLGOOD           PHONE NO : 812-384-3521
HIGHWAY 231 SOUTH,                SE DECISION MADE: 03-MAR-00
2 QUALITY WAY                     510(k) STATEMENT
BLOOMFIELD, IN 47424

DEVICE: MEDAMICUS EPIDURAL INTRODUCER
MEDAMICUS, INC.                   510(k) NO: K994097(TRADITIONAL)
ATTN: DENNIS  MANSON              PHONE NO : 612-559-2613
15301 HWY. 55 WEST                SE DECISION MADE: 01-MAR-00
MINNEAPOLIS, MN 55447             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHALANGEAL FIXATION SYSTEM
MEDCANICA, INC.                   510(k) NO: K994232(TRADITIONAL)
ATTN: AL  WEISENBORN              PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE             SE DECISION MADE: 01-MAR-00
MIAMI, FL 33015                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGHTSURE OPERATION INDICATOR, MODEL SS301
MEDEVICES, INC.                   510(k) NO: K993358(TRADITIONAL)
ATTN: MICHELE H VOVOLKA           PHONE NO : 847-856-0355
PO BOX 848                        SE DECISION MADE: 15-MAR-00
GRAYSLAKE, IL 60030               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG N
MEDI-CULT A/S                     510(k) NO: K991470(TRADITIONAL)
ATTN: RONALD G LEONARDI           PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA              SE DECISION MADE: 07-MAR-00
SAN DIEGO, CA 92131               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SLENDAIR 4000 COMPRESSION SYSTEM
MEDICAL COMPRESSION SYSTEMS (D.B.N510(k) NO: K994057(TRADITIONAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 972 977 18130
117 AHUZAH ST.                    SE DECISION MADE: 03-MAR-00
RA'ANANNA, ISRAEL 43373           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403,
MEDICAL DATA ELECTRONICS, INC.    510(k) NO: K000660(SPECIAL)
ATTN: CEDRIC  NAVARRO             PHONE NO : 818-768-6411
12720 WENTWORTH ST.               SE DECISION MADE: 28-MAR-00
ARLETA, CA 91331                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMAGE X-70 PLUS DENTAL X-RAY UNIT
MEDICAL DEVICE CONSULTANTS, INC.  510(k) NO: K000551(SPECIAL)
ATTN: MARY  MCNAMARA-CULLINANE    PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 16-MAR-00
NORTH ATTLEBORO, MA 02760-4153    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UMBILICAL CORD CLAMP
MEDICAL SALES CO.                 510(k) NO: K994367(TRADITIONAL)
ATTN: JOHN E LINCOLN              PHONE NO : 435-882-4655
P.O. BOX 154                      SE DECISION MADE: 17-MAR-00
TOOELE, UT 84074-0154             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MSP M/K BLADE
MEDICAL STERILE PRODUCTS INC.     510(k) NO: K993122(TRADITIONAL)
ATTN: GARY C DIONNE               PHONE NO :
RD. 413, KM. 0.2                  SE DECISION MADE: 16-MAR-00
RINCON, PR 00677                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K994282(TRADITIONAL)
ATTN: J.I.  HOLLANDER             PHONE NO : 317 152 3244
POORTGEBOUW RIJNSBURGERWEG 10     SE DECISION MADE: 02-MAR-00
2333 AA LEIDEN                    510(k) SUMMARY AVAILABLE FROM FDA
, NETHERLANDS

DEVICE: MCA-601, C-ARM MOBILE
MEDISON RADIOLOGY SYSTEMS, INC.   510(k) NO: K993896(TRADITIONAL)
ATTN: JOHN W LEE                  PHONE NO : 847-729-3333
2000 LEHIGH AVE.                  SE DECISION MADE: 27-MAR-00
GLENVIEW, IL 60025                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SINGLE SIZE TENDON SPACER
MEDIST INTERNATIONAL              510(k) NO: K000019(TRADITIONAL)
ATTN: BERNARD F GRISONI           PHONE NO : 901-380-9411
9160 HIGHWAY 64                   SE DECISION MADE: 29-MAR-00
SUITE 12                          510(k) SUMMARY AVAILABLE FROM FDA
LAKELAND, TN 38002

DEVICE: REVERSO
MEDISYSTEMS CORP.                 510(k) NO: K994306(TRADITIONAL)
ATTN: FREDRIC G SWINDLER          PHONE NO : 206-621-6526
1201 3RD AVE., SUITE 3900         SE DECISION MADE: 20-MAR-00
SEATTLE, WA 98101-3016            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
MEDLINE INDUSTRIES, INC.          510(k) NO: K993170(TRADITIONAL)
ATTN: BETTY A LOCK                PHONE NO : 847-949-3109
1170 NORTHPOINT BLVD.             SE DECISION MADE: 02-MAR-00
WAUKEGAN, IL 60085                510(k) STATEMENT

DEVICE: VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH
MEDPRO TECHNOLOGIES, INC.         510(k) NO: K000369(TRADITIONAL)
ATTN: ART  WARD                   PHONE NO : 813-645-2855
962 ALLEGRO LANE                  SE DECISION MADE: 30-MAR-00
APOLLO BEACH, FL 33572            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LOVE LOCKERS
MEDTECH PRODUCTS LTD.             510(k) NO: K993733(ABBREVIATED)
ATTN: A.V.K.  REDDY               PHONE NO : 009 144 6288829
S-59 20TH STREET                  SE DECISION MADE: 20-MAR-00
ANNA NAGAR WEST                   510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI, INDIA 600 040

DEVICE: DOUBLE SPRINGERS
MEDTECH PRODUCTS LTD.             510(k) NO: K993735(ABBREVIATED)
ATTN: A.V.K.  REDDY               PHONE NO : 914 462 88829
S-59 20TH STREET                  SE DECISION MADE: 20-MAR-00
ANNA NAGAR WEST                   510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI, INDIA 600 040

DEVICE: MIGHTY MAN (DYNAMIC LINKERS)
MEDTECH PRODUCTS LTD.             510(k) NO: K993737(ABBREVIATED)
ATTN: A.V.K.  REDDY               PHONE NO : 009 144 6288829
S-59 20TH STREET                  SE DECISION MADE: 20-MAR-00
ANNA NAGAR WEST                   510(k) SUMMARY AVAILABLE FROM FDA
CHENNAI, INDIA 600 040

DEVICE: MODIFICATION TO CD SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K000453(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 10-MAR-00
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODIFICATION TO CD SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.     510(k) NO: K000476(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 10-MAR-00
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
MEDTRONIC XOMED                   510(k) NO: K000728(TRADITIONAL)
ATTN: DAVID  TIMLIN               PHONE NO : 904-279-7532
6743 SOUTHPOINT DR. N.            SE DECISION MADE: 21-MAR-00
JACKSONVILLE, FL 32216            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZUMA GUIDE CATHETERS
MEDTRONIC, INC.                   510(k) NO: K000677(SPECIAL)
ATTN: FRED L BOUCHER              PHONE NO : 978-777-0042
35-37A CHERRY HILL DR.            SE DECISION MADE: 29-MAR-00
DANVERS, MA 01923                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
MERCURY MEDICAL                   510(k) NO: K000073(TRADITIONAL)
ATTN: MATTHEW  NEKOROSKI          PHONE NO : 978-821-6178
160  SOUTH MAIN STREET            SE DECISION MADE: 01-MAR-00
SUITE A                           510(k) SUMMARY AVAILABLE FROM FDA
MIDDLETON, MA 01949

DEVICE: MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K000659(SPECIAL)
ATTN: CHESTER  MCCOY              PHONE NO : 801-253-1600
1111 SOUTH VELASCO                SE DECISION MADE: 29-MAR-00
ANGLETON, TX 77515                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IN-LINE HEMOSTASIS VALVE
MERIT MEDICAL SYSTEMS, INC.       510(k) NO: K990975(TRADITIONAL)
ATTN: CHESTER  MCCOY              PHONE NO : 801-253-1600
1600 WEST MERIT PKWY.             SE DECISION MADE: 15-MAR-00
SOUTH JORDAN, UT 84095            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRINS MICROSURGICAL SUTURE
MICRINS MICROSURGICAL INSTRUMENTS,510(k) NO: K993970(TRADITIONAL)
ATTN: BERNHARD  TEITZ             PHONE NO : 847-549-1410
28438 BALLARD DR.                 SE DECISION MADE: 30-MAR-00
LAKE FOREST, IL 60045             510(k) STATEMENT

DEVICE: MDI DS-DNA TEST
MICRO DETECT, INC.                510(k) NO: K000477(TRADITIONAL)
ATTN: MEHDI  ALEM                 PHONE NO : 714-832-8234
2852 WALNUT AVE.                  SE DECISION MADE: 01-MAR-00
TUSTIN, CA 92780                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MIKRO-TIP ANGIOGRAPHIC CATHETER
MILLAR INSTRUMENTS, INC.          510(k) NO: K993694(SPECIAL)
ATTN: MIRIELLE  ARCE              PHONE NO : 713-923-9171
6001 GULF FREEWAY, #534-G         SE DECISION MADE: 01-MAR-00
HOUSTON, TX 77023-5417            510(k) STATEMENT

 
DEVICE: ALLON 2000
MTRE ADVANCED TECHNOLOGY LTD.     510(k) NO: K992386(TRADITIONAL)
ATTN: SHOSHANA  FRIEDMAN          PHONE NO : 972 977 18130
117 AHUZAH ST                     SE DECISION MADE: 07-MAR-00
RAANANNA, ISRAEL 43373            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
MULTISAFE SDN BHD                 510(k) NO: K993811(TRADITIONAL)
ATTN: GOH  SEOK HUEI              PHONE NO : 054 348 269
LOT 764                           SE DECISION MADE: 02-MAR-00
BIDOR INDUSTRIAL ESTATE           510(k) STATEMENT
BIDOR, PERAK DARUL RIDZUAN, MALAYSIA 35500

DEVICE: MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
NELLCOR PURITAN BENNETT FRANCE DVP510(k) NO: K993584(ABBREVIATED)
ATTN: MOUSTAFA  ANKI              PHONE NO : 333 834 48500
10 ALLEE PELLETIER DOISY          SE DECISION MADE: 07-MAR-00
VILLERS-LES-NANCY, FRANCE 54601   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BRANEMARK NOVUM
NOBEL BIOCARE USA, INC.           510(k) NO: K000018(TRADITIONAL)
ATTN: KATHLEEN  DRAGOVICH         PHONE NO : 714-282-4800
22725 SAVI RANCH PKWY.            SE DECISION MADE: 30-MAR-00
YORBA LINDA, CA 92887             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NOVA CORDLESS CURING LIGHT
NOVA/DA VINCI SYSTEMS INC.        510(k) NO: K000393(TRADITIONAL)
ATTN: ALAN A CREAMER              PHONE NO : 858-558-9203
9885 MESA RIM                     SE DECISION MADE: 27-MAR-00
SUITE 127                         510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121

DEVICE: SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.
NUCLETRON CORP.                   510(k) NO: K992303(TRADITIONAL)
ATTN: RALPH E SHUPING             PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR.         SE DECISION MADE: 27-MAR-00
COLUMBIA, MD 21046-2133           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GAS FILTER
OLSON MEDICAL SALES, INC.         510(k) NO: K993060(TRADITIONAL)
ATTN: GARRY A COURTNEY            PHONE NO : 410-392-7231
2101 COTTONTAIL LANE              SE DECISION MADE: 28-MAR-00
SOMERSET, NJ 08873                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACT/ALERT MB CULTURE BOTTLE
ORGANON TEKNIKA CORP.             510(k) NO: K000378(TRADITIONAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 02-MAR-00
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
ORTHO DEVELOPMENT CORP.           510(k) NO: K994370(TRADITIONAL)
ATTN: CAROL  FREASIER             PHONE NO : 801-553-9991
106 WEST 12200 SOUTH              SE DECISION MADE: 24-MAR-00
DRAPER, UT 84020                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K000566(SPECIAL)
ATTN: JOSEPH  FALVO               PHONE NO : 716-453-5735
100 INDIGO CREEK DR.              SE DECISION MADE: 09-MAR-00
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGELLAN TIBIAL INTRAMEDULLARY NAIL
ORTHOMATRIX, INC.                 510(k) NO: K992850(TRADITIONAL)
ATTN: BEN  SHAPPLEY               PHONE NO : 901-888-5614
711 CHANEY COVE                   SE DECISION MADE: 10-MAR-00
COLLIERVILLE, TN 38017            510(k) STATEMENT

DEVICE: MAGELLAN HUMERAL INTRAMEDULLARY NAIL
ORTHOMATRIX, INC.                 510(k) NO: K992856(TRADITIONAL)
ATTN: BEN  SHAPPLEY               PHONE NO : 901-888-5614
711 CHANEY COVE                   SE DECISION MADE: 10-MAR-00
COLLIERVILLE, TN 38017            510(k) STATEMENT

DEVICE: CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
OSTEOGENICS BIOMEDICAL, INC.      510(k) NO: K993610(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST DR              SE DECISION MADE: 02-MAR-00
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VOYAGER/VIPER WHEELCHAIR
OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000497(TRADITIONAL)
ATTN: JOHN  HENDRICKSON           PHONE NO : 612-553-9464
3000 XENIUM LN. NORTH             SE DECISION MADE: 08-MAR-00
MINNEAPOLIS, MN 55441             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROTEGE WHEELCHAIR
OTTO BOCK ORTHOPEDIC INDUSTRY, INC510(k) NO: K000602(TRADITIONAL)
ATTN: JOHN  HENDRICKSON           PHONE NO : 612-553-9464
3000 XENIUM LN. NORTH             SE DECISION MADE: 03-MAR-00
MINNEAPOLIS, MN 55441             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THROMBOSTRATE CONTROL PLASMAS
PACIFIC HEMOSTASIS                510(k) NO: K000679(TRADITIONAL)
ATTN: LAURA A WORFOLK             PHONE NO : 704-948-3276
11515 VANSTORY DR.                SE DECISION MADE: 24-MAR-00
HUNTERSVILLE, NC 28078-8144       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PACIFIC SURGICAL PATTIES
PACIFIC SURGICAL INNOVATIONS, INC.510(k) NO: K993019(TRADITIONAL)
ATTN: TERRY  JOHNSTON             PHONE NO : 650-802-6938
360 INDUSTRIAL RD., UNIT H        SE DECISION MADE: 30-MAR-00
SAN CARLOS, CA 94070              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UNIPOLAR NEEDLES
PAJUNK GMBH                       510(k) NO: K000722(TRADITIONAL)
ATTN: BURK A BRANDT               PHONE NO : 541-752-9393
5010 NW CRESCENT VALLEY DRIVE     SE DECISION MADE: 31-MAR-00
CORVALLIS, OR 97330               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGIC
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K993201(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH          SE DECISION MADE: 29-MAR-00
SEREMBAN, NAGERI SEMBILAN         510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300

DEVICE: POSITUBE
PARAPRODUCTS INC.                 510(k) NO: K000045(TRADITIONAL)
ATTN: JAMES  FLORY                PHONE NO : 630-250-7979
1431 INDUSTRIAL DRIVE             SE DECISION MADE: 15-MAR-00
ITASCA, IL 60143                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN
PHAMATECH                         510(k) NO: K000447(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 07-MAR-00
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARELISA SM ANTIBODIES
PHARMACIA & UPJOHN CO.            510(k) NO: K000312(TRADITIONAL)
ATTN: KAREN  MATIS                PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE            SE DECISION MADE: 17-MAR-00
WESTERVILLLE, OH 43082            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
PILLING WECK SURGICAL             510(k) NO: K992174(TRADITIONAL)
ATTN: RICHARD G JONES             PHONE NO : 800-523-6507
420 DELAWARE DR.                  SE DECISION MADE: 23-MAR-00
FORT WASHINGTON, PA 19034         510(k) STATEMENT

DEVICE: DIMEX 2
PLANMECA OY                       510(k) NO: K000454(TRADITIONAL)
ATTN: BOB  PIENKOWSKI             PHONE NO : 630-595-7077
362 BALM COURT                    SE DECISION MADE: 31-MAR-00
WOOD DALE, IL 60191-1273          510(k) STATEMENT

DEVICE: MALE LATEX CONDOM WITH VANILLA FLAVOR
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K994311(ABBREVIATED)
ATTN: LIM KOI  YONG               PHONE NO : 603 874 0784
LOT 1365, 17TH MILES, JALAN       SE DECISION MADE: 21-MAR-00
SUNGAI SEMBILANG                  510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800

DEVICE: MALE LATEX CONDOM 56MM
PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K994312(ABBREVIATED)
ATTN: LIM KOI  YONG               PHONE NO : 603 874 0784
LOT 1365, 17TH MILES, JALAN       SE DECISION MADE: 21-MAR-00
SUNGAI SEMBILANG                  510(k) STATEMENT
JERAM, SELANGOR, MALAYSIA 45800

DEVICE: PORTSETT
PORTSETT, INC.                    510(k) NO: K000085(TRADITIONAL)
ATTN: SALVADORE F PALOMARES       PHONE NO : 949-463-6146
154 VIA LAMPARA                   SE DECISION MADE: 17-MAR-00
RANCHO SANTA MARGARITA, CA 92688  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
PRECISION DYNAMICS CORP.          510(k) NO: K994353(TRADITIONAL)
ATTN: KALYNA  SNYLYK              PHONE NO : 818-897-1111
13880 DEL SUR ST.                 SE DECISION MADE: 22-MAR-00
SAN FERNANDO, CA 91340-3490       510(k) STATEMENT

DEVICE: PROSTEC 125I BRACHYTHERAPY SEEDS
PROSTEC LLC                       510(k) NO: K993280(TRADITIONAL)
ATTN: AL  WEISENBORN              PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE             SE DECISION MADE: 14-MAR-00
MIAMI, FL 33015                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULPDENT CAVITY PREPARATION III
PULPDENT CORP.                    510(k) NO: K994180(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617-926-6666
80 OAKLAND ST.                    SE DECISION MADE: 02-MAR-00
WATERTOWN, MA 02471-0780          510(k) STATEMENT

DEVICE: NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNE
PURITAN-BENNETT IRELAND, LTD.     510(k) NO: K990897(TRADITIONAL)
ATTN: ROBBIE  WALSH               PHONE NO : 353 917 53771
MERVUE                            SE DECISION MADE: 15-MAR-00
GALWAY, IRELAND                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR
QUANTEL MEDICAL                   510(k) NO: K000554(SPECIAL)
ATTN: GEORGE  MYERS               PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH                SE DECISION MADE: 14-MAR-00
HASBROUCK HEIGHTS, NJ 07604       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
QUINTON INSTRUMENT CO.            510(k) NO: K992908(TRADITIONAL)
ATTN: MATTHEW J HEDLUND           PHONE NO : 425-402-2416
3303 MONTE VILLA PKWY.            SE DECISION MADE: 06-MAR-00
BOTHELL, WA 98021-8906            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIONICS LUMBOPERITONEAL SHUNT
RADIONICS, INC.                   510(k) NO: K000057(TRADITIONAL)
ATTN: KEVIN K O'CONNELL           PHONE NO : 800-466-6814
22 TERRY AVE.                     SE DECISION MADE: 20-MAR-00
BURLINGTON, MA 01803              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEVEEN NEEDLE ELECTRODE
RADIOTHERAPEUTICS CORP.           510(k) NO: K000032(TRADITIONAL)
ATTN: GARY  CURTIS                PHONE NO : 408-745-3200
1308 BORREGAS AVENUE              SE DECISION MADE: 30-MAR-00
SUNNYVALE, CA 94089               510(k) STATEMENT

DEVICE: RANDOX COMPLEMENT C4
RANDOX LABORATORIES LTD.          510(k) NO: K000468(TRADITIONAL)
ATTN: P  ARMSTRONG                PHONE NO : 440 289 445294
ARDMORE, DIAMOND ROAD             SE DECISION MADE: 27-MAR-00
CRUMLIN, BT29 4QY CO.             510(k) STATEMENT
ANTRIM, N. IRELAND, IRAN

 
DEVICE: RANDOX COMPLEMENT C3
RANDOX LABORATORIES LTD.          510(k) NO: K000469(TRADITIONAL)
ATTN: R  ARMSTRONG                PHONE NO : 440 289 4422413
ARDMORE, DIAMOND ROAD             SE DECISION MADE: 27-MAR-00
CRUMLIN, BT29 4QY CO.             510(k) SUMMARY AVAILABLE FROM FDA
ANTRIM, N. IRELAND, IRELAND

DEVICE: RANDOX ALBUMIN
RANDOX LABORATORIES LTD.          510(k) NO: K000483(TRADITIONAL)
ATTN: P  ARMSTRONG                PHONE NO : 440 289 4422413
55 DIAMOND RD.                    SE DECISION MADE: 31-MAR-00
CRUMLIN, CO. ANTRIM, IRELAND BT29 510(k) STATEMENT

DEVICE: REICHERT CT200 CONTACT TONOMETER
REICHERT OPHTHALMIC INSTRUMENTS, D510(k) NO: K000288(TRADITIONAL)
ATTN: FRANK J DREXELIUS           PHONE NO : 716-686-4548
3374 WALDEN AVE.                  SE DECISION MADE: 23-MAR-00
DEPEW, NY 14043                   510(k) STATEMENT

DEVICE: M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
RESONANCE TECHNOLOGY, INC.        510(k) NO: K994351(TRADITIONAL)
ATTN: MOKHTAR  ZIARATI            PHONE NO : 818-882-1997
18121 PARTHENIA ST.               SE DECISION MADE: 22-MAR-00
NORTHRIDGE, CA 91325              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIPAP SYNCHRONY HC
RESPIRONICS GEORGIA, INC.         510(k) NO: K992530(ABBREVIATED)
ATTN: DAVID J VANELLA             PHONE NO : 724-733-5866
1001 MURRY RIDGE LANE             SE DECISION MADE: 20-MAR-00
MURRYSVILLE, PA 15668             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K000046(TRADITIONAL)
ATTN: ROBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 30-MAR-00
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K994363(TRADITIONAL)
ATTN: ROBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 06-MAR-00
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
RITA MEDICAL SYSTEMS              510(k) NO: K983214(TRADITIONAL)
ATTN: DAN  BALBIERZ               PHONE NO : 650-390-8500
967 NORTH SHORELINE BLVD.         SE DECISION MADE: 27-MAR-00
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS B-CROSSLAPS CALCHECK
ROCHE DIAGNOSTICS CORP.           510(k) NO: K000042(TRADITIONAL)
ATTN: KAY A LAPS                  PHONE NO : 317-576-3544
9115 HAGUE ROAD                   SE DECISION MADE: 17-MAR-00
P.O. BOX 50457                    510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457

 
DEVICE: ELECSYS CORTISOL TEST SYSTEM
ROCHE DIAGNOSTICS CORP.           510(k) NO: K000270(TRADITIONAL)
ATTN: PRISCILLA A HAMMILL         PHONE NO : 317-576-3723
9115 HAGUE RD.                    SE DECISION MADE: 07-MAR-00
INDIANAPOLIS, IN 46250-0457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECSYS CORTISOL CALCHECK
ROCHE DIAGNOSTICS CORP.           510(k) NO: K000576(TRADITIONAL)
ATTN: KAY A TAYLOR                PHONE NO : 317-576-3544
9115 HAGUE RD.                    SE DECISION MADE: 21-MAR-00
INDIANAPOLIS, IN 46250-0457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EMBRYON GIFT TRANSFER CATHETERS/SETS
ROCKET MEDICAL PLC                510(k) NO: K000656(TRADITIONAL)
ATTN: LES  TODD                   PHONE NO : 011 441 914166776
WARE INDUSTRIAL ESTATE            SE DECISION MADE: 09-MAR-00
WASHINGTON, TYNE & WEAR, UNITED KI510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROTHERM RF CANNULA
ROCKET MEDICAL PLC                510(k) NO: K994344(TRADITIONAL)
ATTN: LES  TODD                   PHONE NO : 011 441 914166776
FACTORIES 3 & 4,                  SE DECISION MADE: 21-MAR-00
WEAR INDUSTRIAL ESTATE            510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, TYNE & WEAR, UNITED KINGDOM NE37 1NE

DEVICE: RUSCH MANUAL RESUSCITATOR BAG
RUSCH, INC.                       510(k) NO: K993194(TRADITIONAL)
ATTN: RONALD  YOUNG               PHONE NO : 770-623-0816
2450 MEADOWBROOK PKWY.            SE DECISION MADE: 24-MAR-00
DULUTH, GA 30096                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAS STREP A TEST
SA SCIENTIFIC, INC.               510(k) NO: K993456(TRADITIONAL)
ATTN: HARBI A SHADFAN             PHONE NO : 210-699-8800
4919 GOLDEN QUAIL                 SE DECISION MADE: 07-MAR-00
SAN ANTONIO, TX 78240             510(k) STATEMENT

DEVICE: SOLOGUARD LOCKING PLUS SYRINGE
SAFEGUARD MEDICAL PRODUCTS, INC.  510(k) NO: K993609(TRADITIONAL)
ATTN: PATRICK  GRANT              PHONE NO : 781-935-2275
52 DRAGON COURT                   SE DECISION MADE: 17-MAR-00
WOBURN, MA 01801                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN
SAFESKIN CORP.                    510(k) NO: K993117(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO         PHONE NO : 619-509-7010
12671 HIGH BLUFF DR.              SE DECISION MADE: 02-MAR-00
SAN DIEGO, CA 92130               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IO-DRIVE
SELECTIVE MED COMPONENTS, INC.    510(k) NO: K993081(TRADITIONAL)
ATTN: RICK  FISHER                PHONE NO : 740-397-7838
6 S. MECHANIC ST.                 SE DECISION MADE: 03-MAR-00
MOUNT VERNON, OH 43050            510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
SELFCARE, INC.                    510(k) NO: K000583(SPECIAL)
ATTN: CAROL A ADILETTO            PHONE NO : 781-647-3900
200 PROSPECT STREET               SE DECISION MADE: 17-MAR-00
WALTHAM, MA 02453                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
SENORX INC.                       510(k) NO: K000060(TRADITIONAL)
ATTN: AMY  BOUCLY                 PHONE NO : 949-454-1300
13766 ALTON PKWY., SUITE 144      SE DECISION MADE: 27-MAR-00
IRVINE, CA 92618                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, W
SGMP CO., LTD.                    510(k) NO: K000488(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 20-MAR-00
SPARKS, NV 89434                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT,
SGMP CO., LTD.                    510(k) NO: K000671(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD        SE DECISION MADE: 29-MAR-00
SPARKS, NV 89434                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
SHEEN MORE ENT. CO., LTD.         510(k) NO: K000226(TRADITIONAL)
ATTN: KEN  HUANG                  PHONE NO : 011 886 55575937
NO.16, TOU KUNG SIX RD.           SE DECISION MADE: 02-MAR-00
TOU-LIU EXPANDED INDUST. AREA     510(k) STATEMENT
TOU-LIU, YUN-LIN, CHINA (TAIWAN)

DEVICE: SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K992554(TRADITIONAL)
ATTN: KAREN  ABEL                 PHONE NO : 909-590-9358
13945 MAGNOLIA AVE                SE DECISION MADE: 29-MAR-00
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K992821(TRADITIONAL)
ATTN: KAREN  ABELL                PHONE NO : 909-548-4828
12390 EAST END AVE                SE DECISION MADE: 10-MAR-00
CHINO, CA 91710                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 S
SHIMADZU MEDICAL SYSTEMS          510(k) NO: K994431(TRADITIONAL)
ATTN: MICHAEL  FISHBACK           PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE.          SE DECISION MADE: 23-MAR-00
TORRANCE, CA 90502                510(k) STATEMENT

DEVICE: WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYT
SIMS PORTEX LTD.                  510(k) NO: K000628(TRADITIONAL)
ATTN: GILES  BISHOP               PHONE NO : 44 130 3260551
HYTHE                             SE DECISION MADE: 13-MAR-00
KENT, UNITED KINGDOM CT21 6JL     510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: VOCOM IMPLANT- 8MM
SMITH & NEPHEW, INC.              510(k) NO: K000533(TRADITIONAL)
ATTN: ALICIA  FARAGE              PHONE NO : 901-373-0279
2925 APPLING ROAD                 SE DECISION MADE: 01-MAR-00
BARTLETT, TN 38133                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW SUTURELOK, MODEL 7207321
SMITH & NEPHEW, INC.              510(k) NO: K000717(SPECIAL)
ATTN: NICHOLAS  CONDAKES          PHONE NO : 508-261-3770
130 FORBES BLVD.                  SE DECISION MADE: 30-MAR-00
MANSFIELD, MA 02048               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYONICS ELECTROBLADE
SMITH & NEPHEW, INC.              510(k) NO: K994365(TRADITIONAL)
ATTN: DEBORAH  CONNORS            PHONE NO : 978-749-1495
160 DASCOMB RD.                   SE DECISION MADE: 13-MAR-00
ANDOVER, MA 01810                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLORADO II SPINAL SYSTEM
SOFAMOR DANEK USA,INC.            510(k) NO: K984360(TRADITIONAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 30-MAR-00
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTROSURGICAL GENERATOR, MODEL S1
SOMNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K000501(TRADITIONAL)
ATTN: STEVEN J OJALA              PHONE NO : 408-617-3434
285 NORTH WOLFE RD.               SE DECISION MADE: 17-MAR-00
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BABY FACE
SONORA MEDICAL SYSTEMS            510(k) NO: K994385(TRADITIONAL)
ATTN: COLLEEN  HITTLE             PHONE NO : 303-682-5871
1830 BOSTON AVE                   SE DECISION MADE: 16-MAR-00
SUITE D                           510(k) SUMMARY AVAILABLE FROM FDA
LONGMONT, CO 80501

DEVICE: FERTILOSCOPY KIT FH 1.29/FTO 1.40
SOPRANE S.A.                      510(k) NO: K992655(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202-637-5813
555 THIRTEENTH ST., N.W.          SE DECISION MADE: 13-MAR-00
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S57D DIGITAL OPERATING ROOM CAMERA
SOPRO                             510(k) NO: K000422(TRADITIONAL)
ATTN: PIERRE  MONTILLOT           PHONE NO : 33 491 270727
PLACE ST. CHRISTOPHE              SE DECISION MADE: 31-MAR-00
LES ACCATES-LA VALENTINE          510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011

DEVICE: S52D DIGITAL VIDEO LAPAROSCOPE
SOPRO                             510(k) NO: K000423(TRADITIONAL)
ATTN: PIERRE  MONTILLOT           PHONE NO : 33 491 270727
PLACE ST. CHRISTOPHE              SE DECISION MADE: 31-MAR-00
LES ACCATES-LA VALENTINE          510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011

 
DEVICE: S51D DIGITAL ENDOSCOPY CAMERA
SOPRO                             510(k) NO: K000424(TRADITIONAL)
ATTN: PIERRE  MONTILLOT           PHONE NO : 33 491 270727
PLACE ST. CHRISTOPHE              SE DECISION MADE: 31-MAR-00
LES ACCATES-LA VALENTINE          510(k) SUMMARY AVAILABLE FROM FDA
MARSEILLE, FRANCE 13011

DEVICE: 125-IMPLANT SEEDS, MODEL STM1250
SOURCETECH MEDICAL, L.L.C.        510(k) NO: K991881(TRADITIONAL)
ATTN: DAVID T SIERACKI            PHONE NO : 630-933-7610
295 E. LIES RD.                   SE DECISION MADE: 16-MAR-00
CAROL STREAM, IL 60188            510(k) STATEMENT

DEVICE: SPECIALTY 42 9HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEA
SPECIALTY ULTRAVISION, INC.       510(k) NO: K000376(TRADITIONAL)
ATTN: GAROLD L EDWARDS            PHONE NO : 408-341-0700
307 ORCHARD CITY DR.              SE DECISION MADE: 21-MAR-00
CAMPBELL, CA 95008                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAUTERY FORCEPS WITH FOOTSWITCH
STARION INSTRUMENTS               510(k) NO: K000250(TRADITIONAL)
ATTN: BRIAN  GRIGSBY              PHONE NO : 408-741-8773
20665 4TH ST.                     SE DECISION MADE: 07-MAR-00
SARATOGA, CA 95070                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STARION CAUTERY HOOK
STARION INSTRUMENTS               510(k) NO: K000296(TRADITIONAL)
ATTN: BRIAN  GRIGSBY              PHONE NO : 408-741-8773
20665 4TH ST.                     SE DECISION MADE: 07-MAR-00
SARATOGA, CA 95070                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
STD MFG., INC.                    510(k) NO: K000608(TRADITIONAL)
ATTN: JIM  LOUSARARIAN            PHONE NO : 301-594-3090
1063 TURNPIKE ST.                 SE DECISION MADE: 07-MAR-00
STOUGHTON, MA 02072               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STERIS AMSCO MILLENNIUM STEAM STERILIZER
STERIS CORP.                      510(k) NO: K000077(SPECIAL)
ATTN: RAYMOND  URSICK             PHONE NO : 440-392-7016
5960 HEISELY RD.                  SE DECISION MADE: 17-MAR-00
MENTOR, OH 44060                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STEAM/EO RECORD CARD, MODEL CI 121
STERITEC PRODUCTS MFG. CO., INC.  510(k) NO: K000502(SPECIAL)
ATTN: LINDA  NELSON               PHONE NO : 303-660-4201
599 TOPEKA WAY                    SE DECISION MADE: 14-MAR-00
SUITE 700                         510(k) STATEMENT
CASTLE ROCK, CO 80104

DEVICE: SYNOCTA ANGLED ABUTMENTS
STRAUMANN USA                     510(k) NO: K994119(TRADITIONAL)
ATTN: LINDA  JALBERT              PHONE NO : 800-448-8168
RESERVOIR PLACE,                  SE DECISION MADE: 17-MAR-00
1601 TRAPELO ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02154

 
DEVICE: CELL-CHEX
STRECK LABORATORIES, INC.         510(k) NO: K000076(TRADITIONAL)
ATTN: PAUL  KITTELSON             PHONE NO : 402-333-6017
14124 INDUSTRIAL RD.              SE DECISION MADE: 03-MAR-00
OMAHA, NE 68145-0625              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RETIC CHEX LINEARITY
STRECK LABORATORIES, INC.         510(k) NO: K000115(TRADITIONAL)
ATTN: PAUL  KITTELSON             PHONE NO : 402-691-7465
14124 INDUSTRIAL RD.              SE DECISION MADE: 27-MAR-00
OMAHA, NE 68145-0625              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
SULZER ORTHOPEDICS, INC.          510(k) NO: K993259(TRADITIONAL)
ATTN: MITCHELL A DHORITY          PHONE NO : 512-432-9202
9900 SPECTRUM DR.                 SE DECISION MADE: 10-MAR-00
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
SUPERMAX GLOVE MANUFACTURING SDN B510(k) NO: K000644(TRADITIONAL)
ATTN: STANLEY  THAI               PHONE NO :
47000 SUNGAI BULOH                SE DECISION MADE: 17-MAR-00
SELANGOR, MALAYSIA                510(k) STATEMENT

DEVICE: SURGI-VISION ESOPHAGEAL STYLET COIL
SURGI-VISION, INC.                510(k) NO: K994436(TRADITIONAL)
ATTN: NANCY E TAYLOR              PHONE NO : 410-730-8998
9250 RUMSEY RD., SUITE 100        SE DECISION MADE: 14-MAR-00
COLUMBIA, MD 21045                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K994355(TRADITIONAL)
ATTN: ANGELIQUE S DESTRUEL        PHONE NO : 303-439-9709
530 COMPTON ST.                   SE DECISION MADE: 22-MAR-00
BROOMFIELD, CO 80020              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK85
SURGIN SURGICAL INSTRUMENTATION, I510(k) NO: K994015(TRADITIONAL)
ATTN: DON  HARR                   PHONE NO : 714-832-6300
14762 BENTLEY CIRCLE              SE DECISION MADE: 15-MAR-00
TUSTIN, CA 92680                  510(k) STATEMENT

DEVICE: SUPERSTITCH
SUTURA, INC.                      510(k) NO: K994087(TRADITIONAL)
ATTN: DAVE  BARRY                 PHONE NO : 714-437-9801
17080 NEWHOPE ST.                 SE DECISION MADE: 01-MAR-00
FOUNTAIN VALLEY, CA 92708         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELLEGLASS HP OPACEOUS DENTIN
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K000269(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE          SE DECISION MADE: 23-MAR-00
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BELLEGLASS HP TRANSLUCENT DENTIN
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K000436(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE          SE DECISION MADE: 24-MAR-00
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOLO ORTHO 2
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K994309(TRADITIONAL)
ATTN: WENDY  URTEL                PHONE NO : 714-516-7425
1717 WEST COLLINS AVENUE          SE DECISION MADE: 17-MAR-00
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
SYNTHES (USA)                     510(k) NO: K000066(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 610-647-9700
1690 RUSSELL ROAD                 SE DECISION MADE: 15-MAR-00
POST OFFICE BOX 1766              510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: SYNTHES BUTTON PLATE
SYNTHES (USA)                     510(k) NO: K994364(TRADITIONAL)
ATTN: SHERI L MUSGNUNG            PHONE NO : 610-647-9700
1690 RUSSELL ROAD                 SE DECISION MADE: 15-MAR-00
PAOLI, PA 19301                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO SYNTHES USS
SYNTHES SPINE                     510(k) NO: K000450(SPECIAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
P.O. BOX 0548                     SE DECISION MADE: 10-MAR-00
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: SYNTHES ANTERIOR CSLP SYSTEM
SYNTHES SPINE                     510(k) NO: K000536(SPECIAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
P.O. BOX 0548                     SE DECISION MADE: 15-MAR-00
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: SYNTHES ANTERIOR CSLP SYSTEM
SYNTHES SPINE                     510(k) NO: K000742(SPECIAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
P.O. BOX 0548                     SE DECISION MADE: 29-MAR-00
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
SYVA CO., DADE BEHRING INC.       510(k) NO: K000600(TRADITIONAL)
ATTN: PAUL L ROGERS               PHONE NO : 408-239-2309
P.O. BOX 49013                    SE DECISION MADE: 27-MAR-00
SAN JOSE, CA 95161-9013           510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
TALIA TECHNOLOGY LTD.             510(k) NO: K000731(SPECIAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
COLUMBIA SQUARE                   SE DECISION MADE: 31-MAR-00
555 THIRTEENTH STREET N.W.        510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109

DEVICE: CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULM
TERUMO CORP.                      510(k) NO: K993189(TRADITIONAL)
ATTN: GARRY A COURTNEY            PHONE NO : 800-283-7866
125 BLUE BALL RD                  SE DECISION MADE: 01-MAR-00
ELKTON, MD 21921                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TERUMO NEEDLE WITH LOCKING SHEATH
TERUMO MEDICAL CORP.              510(k) NO: K000387(ABBREVIATED)
ATTN: YUK-TING  LEWIS             PHONE NO : 410-392-7213
125 BLUE BALL ROAD                SE DECISION MADE: 02-MAR-00
ELKTON, MD 21921                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TFX MEDICAL INTRODUCER ASSEMBLY
TFX MEDICAL, INC.                 510(k) NO: K993191(TRADITIONAL)
ATTN: JULIA A BEAUMONT            PHONE NO : 603-532-7706
TALL PINES PARK                   SE DECISION MADE: 24-MAR-00
JAFFREY, NH 03452                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYCURE ORAL / HYCURE ORAL SMART GEL
THE HYMED GROUP CORP.             510(k) NO: K994339(TRADITIONAL)
ATTN: ANITA M PETITO              PHONE NO : 610-865-9876
1890 BUCKNELL DR.                 SE DECISION MADE: 22-MAR-00
BETHLEHEM, PA 18015               510(k) STATEMENT

DEVICE: NAC Y-ADP
THE KIPP GROUP                    510(k) NO: K000343(TRADITIONAL)
ATTN: GARY  WERSCHMIDT            PHONE NO : 909-390-9080
930 WANAMAKER AVE.                SE DECISION MADE: 01-MAR-00
ONTARIO, CA 91761                 510(k) STATEMENT

DEVICE: LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOC
THE LIFESTYLE CO., INC.           510(k) NO: K000529(TRADITIONAL)
ATTN: MARTIN  RIEHM               PHONE NO : 732-972-8585
712 GINESI DR.                    SE DECISION MADE: 21-MAR-00
MORGANVILLE, NJ 07751             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIE
THE OLYMPUS OPTICAL CO.           510(k) NO: K993041(TRADITIONAL)
ATTN: ROBERT  SHIFF               PHONE NO : 973-227-1830
1129 BLOOMFIELD AVE.              SE DECISION MADE: 30-MAR-00
WEST CALDWELL, NJ 07006           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NONLINEAR TAPER LAG SCREW
THEKEN SURGICAL                   510(k) NO: K994382(TRADITIONAL)
ATTN: LUKAS  EISERMANN            PHONE NO : 330-753-7451
1100 NOLA AVENUE                  SE DECISION MADE: 10-MAR-00
BARBERTON, OH 44203               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: BITEM LOCK, MODELS SW006, SW012
THERMOELASTIC TECHNOLOGIES, INC.  510(k) NO: K994357(TRADITIONAL)
ATTN: ART  WARD                   PHONE NO : 813-645-2855
3234 ELLA LANE                    SE DECISION MADE: 14-MAR-00
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
THERMOGEAR, INC.                  510(k) NO: K991684(TRADITIONAL)
ATTN: R.  WAYNE FIELDS            PHONE NO : 503-624-1415
18005 LOWER BOONES FERRY RD.      SE DECISION MADE: 01-MAR-00
TIGARD, OR 97224                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS SHOULDER FRACTURE SYSTEM
TORNIER S.A.                      510(k) NO: K994392(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 10-MAR-00
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389

DEVICE: SUPERGUARD SAFETY SYRINGE
U.S. SAFETY SYRINGES CO., INC.    510(k) NO: K990831(TRADITIONAL)
ATTN: JAMES  GINESI               PHONE NO : 954-561-9500
1290 EAST OAKLAND PARK BLVD.      SE DECISION MADE: 08-MAR-00
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
FORT LAUDERDALE, FL 33334-4447

DEVICE: ULTICARE DISPOSABLE SYRINGE
ULTIMED, INC.                     510(k) NO: K994230(TRADITIONAL)
ATTN: CHARLES W ERICKSON          PHONE NO : 651-291-7909
287 EAST 6TH STREET               SE DECISION MADE: 24-MAR-00
ST. PAUL, MN 55101                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3S INJECTOR-CT CONTRAST DELIVERY SYSTEM
UNIMACHS CORP.                    510(k) NO: K983826(TRADITIONAL)
ATTN: EDUARDO  MARCH              PHONE NO : 301-986-4440
7475 WISCONSIN AVENUE,            SE DECISION MADE: 23-MAR-00
SUITE 850                         510(k) SUMMARY AVAILABLE FROM FDA
BETHESDA, MD 20814

DEVICE: SPIRAL RADIUS RODDING SYSTEM
UNITED STATES SURGICAL CORP.      510(k) NO: K000009(ABBREVIATED)
ATTN: LUIS  NESPRIDO              PHONE NO : 203-845-1552
150 GLOVER AVE.                   SE DECISION MADE: 10-MAR-00
NORWALK, CT 06856                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOFILAMENT BIOSYN SUTURE
UNITED STATES SURGICAL CORP.      510(k) NO: K000037(TRADITIONAL)
ATTN: SETH A SCHULMAN             PHONE NO : 203-845-4519
150 GLOVER AVE.                   SE DECISION MADE: 30-MAR-00
NORWALK, CT 06856                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
VALLEYLAB, INC.                   510(k) NO: K994428(ABBREVIATED)
ATTN: ROBERT C MOORE JR           PHONE NO : 800-265-8522
5920 LONGBOW DR.                  SE DECISION MADE: 07-MAR-00
P.O. BOX 9015                     510(k) SUMMARY AVAILABLE FROM FDA
BOULDER, CO 80301

 
DEVICE: BRACHYVISION 6.0
VARIAN ASSOC., INC.               510(k) NO: K992762(TRADITIONAL)
ATTN: LINDA S NASH                PHONE NO : 650-424-6990
3045 HANOVER STREET               SE DECISION MADE: 09-MAR-00
PALO ALTO, CA 94304               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LEMAITRE IRRIGATION CATHETER
VASCUTECH, INC.                   510(k) NO: K992933(TRADITIONAL)
ATTN: TRENT G KAMKE               PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE            SE DECISION MADE: 08-MAR-00
BURLINGTON, MA 01803              510(k) STATEMENT

DEVICE: LEMAITRE VENOUS THROMBECTOMY CATHETER
VASCUTECH, INC.                   510(k) NO: K992934(TRADITIONAL)
ATTN: TRENT G KAMKE               PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE            SE DECISION MADE: 01-MAR-00
BURLINGTON, MA 01803              510(k) STATEMENT

DEVICE: VENUSA, LTD. EXTENSION SET WITH FILTER
VENUSA LTD.                       510(k) NO: K994429(TRADITIONAL)
ATTN: ROSS  MAGLADRY              PHONE NO : 915-771-9112
31C BUTTERFIELD TRAIL             SE DECISION MADE: 03-MAR-00
EL PASO, TX 79906                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OVES CERVICAL CAP
VEOS LTD.                         510(k) NO: K993953(TRADITIONAL)
ATTN: PEGGY S DANNENBAUM          PHONE NO :
273 MARKET SQUARE CT., #12        SE DECISION MADE: 21-MAR-00
LAKE FOREST, IL 60045             510(k) STATEMENT

DEVICE: VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
VIDEOLABS INC.                    510(k) NO: K000229(TRADITIONAL)
ATTN: FRANK B FREEDMAN            PHONE NO : 612-593-5541
2530 PENNSYLVANIA AVENUE          SE DECISION MADE: 21-MAR-00
SAINT LOUIS PARK, MN 55426        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
VISUALIZATION TECHNOLOGY, INC.    510(k) NO: K994270(TRADITIONAL)
ATTN: NORMA  LEMAY                PHONE NO : 978-933-1000
200 RESEARCH DR.                  SE DECISION MADE: 09-MAR-00
WILMINGTON, MA 01887              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
VSM MEDTECH LTD.                  510(k) NO: K994423(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202-637-5813
555 13TH STREET NW                SE DECISION MADE: 28-MAR-00
WASHINGTON, DC 20004-1109         510(k) STATEMENT

DEVICE: WESCO BLANKET
WESCO, INC.                       510(k) NO: K981093(TRADITIONAL)
ATTN: ARLEN C WEST                PHONE NO : 309-699-7011
921 SUNSET DRIVE                  SE DECISION MADE: 28-MAR-00
EAST PEORIA, IL 61611             510(k) STATEMENT

 
DEVICE: DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LE
WESLEY JESSEN CORP.               510(k) NO: K000439(TRADITIONAL)
ATTN: JOSEPH F FOOS               PHONE NO : 847-294-3306
333 EAST HOWARD AVE.              SE DECISION MADE: 20-MAR-00
DES PLAINES, IL 60018             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS
WESLEY JESSEN CORP.               510(k) NO: K994335(TRADITIONAL)
ATTN: JOSEPH F FOOS               PHONE NO : 847-294-3306
333 EAST HOWARD AVE.              SE DECISION MADE: 20-MAR-00
DES PLAINES, IL 60018             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
WILSON-COOK MEDICAL, INC.         510(k) NO: K000086(TRADITIONAL)
ATTN: MARGARET J POSNER           PHONE NO : 336-744-0157
4900 BETHANIA STATION RD.         SE DECISION MADE: 15-MAR-00
& 5951 GRASSY CREEK BLVD.         510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27105

DEVICE: CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K992481(TRADITIONAL)
ATTN: H.  SEMM                    PHONE NO : 49 0 8104/89080
RUDOLF-DIESEL-RING 20             SE DECISION MADE: 17-MAR-00
SAUERLACH, GERMANY D-82054        510(k) STATEMENT

DEVICE: THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
WISAP GESELLSCHAFT FUR WISSENSCHAF510(k) NO: K992513(TRADITIONAL)
ATTN: HORST  SEMM                 PHONE NO : 490 810 4/8908-0
RUDOLF-DIESEL-RING 20             SE DECISION MADE: 17-MAR-00
SAUERLACH, GERMANY D-82054        510(k) STATEMENT

DEVICE: RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
WOODSIDE BIOMEDICAL, INC.         510(k) NO: K994387(TRADITIONAL)
ATTN: CAROL  PATTERSON            PHONE NO : 949-462-0900
21911 ERIE LANE                   SE DECISION MADE: 16-MAR-00
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
XIMED MEDICAL/PROSURG.            510(k) NO: K994151(TRADITIONAL)
ATTN: LEE  BUI                    PHONE NO : 408-945-4040
2195 TRADE ZONE BLVD.             SE DECISION MADE: 01-MAR-00
SAN JOSE, CA 95131                510(k) STATEMENT

DEVICE: LOCATOR IMPLANT ANCHOR
ZEST ANCHORS, INC.                510(k) NO: K994257(TRADITIONAL)
ATTN: PAUL  ZUEST                 PHONE NO : 760-743-7744
2061 WINERIDGE PL., SUITE 100     SE DECISION MADE: 17-MAR-00
ESCONDIDO, CA 92029               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ZMR HIP SYSTEM-POROUS REVISION
ZIMMER, INC.                      510(k) NO: K994286(TRADITIONAL)
ATTN: KAREN  CAIN                 PHONE NO : 219-372-4219
P.O. BOX 708                      SE DECISION MADE: 10-MAR-00
WARSAW, IN 46581-0708             510(k) SUMMARY AVAILABLE FROM FDA

 

 
                                 TOTAL 510(k)s THIS PERIOD   331
                                 TOTAL WITH SUMMARIES        266
                                 TOTAL WITH STATEMENTS        65