December 1999 510(k) Clearances

DEVICE: A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSUR
A & D ENGINEERING, INC.           510(k) NO: K993888(TRADITIONAL)
ATTN: JERRY  WANG                 PHONE NO : 408-263-5333
1555 MC CANDLESS DR.              SE DECISION MADE: 20-DEC-99
MILPITAS, CA 95035                510(k) STATEMENT

DEVICE: A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32,
A-MED SYSTEMS, INC.               510(k) NO: K991541(TRADITIONAL)
ATTN: ROBERTA  THOMPSON           PHONE NO : 916-375-7400
2491 BOATMAN AVE.                 SE DECISION MADE: 28-DEC-99
WEST SACRAMENTO, CA 95691         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRUCTOSAMINE, MODEL FR 106-01
A.P. TOTAL CARE, INC.             510(k) NO: K991246(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-335-9277
70 HAWLEY AVE,                    SE DECISION MADE: 16-DEC-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOT
ABBOTT LABORATORIES, INC.         510(k) NO: K994039(SPECIAL)
ATTN: JERRY  JENNINGS             PHONE NO : 847-935-4977
D-389, BLDG. AP30                 SE DECISION MADE: 22-DEC-99
200 ABBOTT PARK ROAD              510(k) STATEMENT
ABBOTT PARK, IL 60064-3537

DEVICE: ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES
ACCUMETRICS INC.                  510(k) NO: K992531(TRADITIONAL)
ATTN: FRANCES E HARRISON          PHONE NO : 619-404-8235
3985 B SORRENTO VALLEY BLVD.      SE DECISION MADE: 21-DEC-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
ACIST MEDICAL SYSTEMS             510(k) NO: K993774(SPECIAL)
ATTN: CARL M BEAURLINE            PHONE NO : 612-955-9319
7450 FLYING CLOUDS DR.            SE DECISION MADE: 07-DEC-99
SUITE 150                         510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344

DEVICE: ACON ONE STEP PREGNANCY TEST STRIP (URINE)
ACON LABORATORIES, INC.           510(k) NO: K993203(TRADITIONAL)
ATTN: NORA C.R.  YORK             PHONE NO : 858-535-2030
11175 FLINTKOTE AVE., #F & G      SE DECISION MADE: 01-DEC-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
ACON LABORATORIES, INC.           510(k) NO: K993317(TRADITIONAL)
ATTN: NORA C.R.  YORK             PHONE NO : 858-535-2030
11175 FLINTKOTE AVE., #F & G      SE DECISION MADE: 01-DEC-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
ACUSON CORP.                      510(k) NO: K992631(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN           PHONE NO : 202-637-5813
555 13TH ST., N.W.                SE DECISION MADE: 15-DEC-99
WASHINGTON, DC 20004-1109         510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPACE-OR RETRACTOR
ADVANCED SURGICAL CONCEPTS (ASC)  510(k) NO: K993544(TRADITIONAL)
ATTN: MARY MCNAMARA  CULLINANE    PHONE NO : 508-643-2237
49 PLAIN STREET                   SE DECISION MADE: 22-DEC-99
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATR 3000, ATR 2000, IMPLANT-PRO
ADVANCED TECHNOLOGY RESEARCH S.A.S510(k) NO: K991401(TRADITIONAL)
ATTN: CAROL   A  PATTERSON        PHONE NO : 949-462-0900
21911 ERIE LANE                   SE DECISION MADE: 15-DEC-99
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AROMATIC AND FLAVORED TONGUE DEPRESSOR
AGA PLASTIC IND. COM. LTDA.       510(k) NO: K992995(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK      PHONE NO : 203-431-1511
55 NORTHERN BLVD                  SE DECISION MADE: 09-DEC-99
SUITE 200                         510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021

DEVICE: SIMPLIFY D-DIMER, MODEL DCGK1
AGEN BIOMEDICAL LTD.              510(k) NO: K993276(TRADITIONAL)
ATTN: RUSSEL  RICHARDS            PHONE NO : 617 337 06300
7 & 11 DURBELL ST.,               SE DECISION MADE: 14-DEC-99
ACACIA RIDGE                      510(k) STATEMENT
BRISBANE, AUSTRALIA 4110

DEVICE: VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
AGILENT TECHNOLOGIES, INC.        510(k) NO: K993907(SPECIAL)
ATTN: DAVE  OSBORN                PHONE NO : 978-659-3176
3000 MINUTEMAN RD.                SE DECISION MADE: 06-DEC-99
ANDOVER, MA 01810-1099            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALATECH LATEX CONDOM
ALATECH, LLC                      510(k) NO: K993887(ABBREVIATED)
ATTN: WAYNE L GAINEY              PHONE NO : 334-886-9337
595 EAST LAWRENCE HARRIS HWY      SE DECISION MADE: 20-DEC-99
SLOCOMB, AL 36375                 510(k) STATEMENT

DEVICE: AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K993833(SPECIAL)
ATTN: SHARON  ROBBINS             PHONE NO : 847-785-3311
1500 WAUKEGAN RD.                 SE DECISION MADE: 10-DEC-99
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-
ALTHIN MEDICAL, INC.              510(k) NO: K990643(TRADITIONAL)
ATTN: AMAURY  SANCHEZ             PHONE NO : 305-823-5240
14620 N.W. 60TH AVE.              SE DECISION MADE: 07-DEC-99
MIAMI LAKES, FL 33014-9308        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJ
AMERICAN BIO MEDICA CORP.         510(k) NO: K993796(TRADITIONAL)
ATTN: HENRY  WELLS                PHONE NO : 800-227-1243
300 FAIRVIEW AVE.                 SE DECISION MADE: 21-DEC-99
HUDSON, NY 12534                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: IMPLANTABLE CLIP FOR GENERAL SURGERY
APPLIED MEDICAL RESOURCES         510(k) NO: K993135(TRADITIONAL)
ATTN: ANIL  BHALANI               PHONE NO : 949-582-6120
26051 MERIT CIRCLE, #104          SE DECISION MADE: 01-DEC-99
LAGUNA HILLS, CA 92653            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: URETERAL ACCESS SHEATH SET - NEW MODELS
APPLIED MEDICAL RESOURCES         510(k) NO: K993650(TRADITIONAL)
ATTN: ANIL  BHALANI               PHONE NO : 949-582-6243
26051 MERIT CIRCLE, #104          SE DECISION MADE: 28-DEC-99
LAGUNA HILLS, CA 92653            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
ARNOLD & RICHTER CINE TECHNIK     510(k) NO: K993283(TRADITIONAL)
ATTN: THOMAS  POPP                PHONE NO : 49 89 38091289
89 TURKENSTRASSE                  SE DECISION MADE: 29-DEC-99
MUNICH, GERMANY 80799             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLATELETWORKS
ARRAY MEDICAL, INC.               510(k) NO: K990398(TRADITIONAL)
ATTN: DAVID  CARVILLE             PHONE NO : 908-707-8872
ONE HARVARD WAY, SUITE 5          SE DECISION MADE: 01-DEC-99
HILLSBOROUGH CAMPUS               510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876

DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH. POWERCORD,
ARTHROCARE CORP.                  510(k) NO: K992581(TRADITIONAL)
ATTN: BRUCE  PROTHRO              PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE.           SE DECISION MADE: 09-DEC-99
SUNNYVALE, CA 94086               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AVL OPTI CRITICAL CARE ANALYZER
AVL SCIENTIFIC CORP.              510(k) NO: K993837(TRADITIONAL)
ATTN: RANDY  BYRD                 PHONE NO : 770-576-5000
235 HEMBREE PARK DR.              SE DECISION MADE: 16-DEC-99
ROSWELL, GA 30076                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
AXIS                              510(k) NO: K992502(TRADITIONAL)
ATTN: RONALD G LEONARDI           PHONE NO : 619-586-0751
PO BOX 262069                     SE DECISION MADE: 21-DEC-99
SAN DIEGO, CA 92196               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
BAYER CORP.                       510(k) NO: K993309(TRADITIONAL)
ATTN: WILLIAM J PIGNATO           PHONE NO : 508-359-3825
63 NORTH ST.                      SE DECISION MADE: 06-DEC-99
MEDFIELD, MA 02052                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNO
BAYER CORP.                       510(k) NO: K993353(TRADITIONAL)
ATTN: GABRIEL J MURACA JR         PHONE NO : 914-631-8000
511 BENEDICT AVE.                 SE DECISION MADE: 06-DEC-99
TARRYTOWN, NY 10591-5097          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE
BAYER CORP.                       510(k) NO: K993571(TRADITIONAL)
ATTN: THOMAS F FLYNN              PHONE NO : 508-359-3877
63 NORTH ST.                      SE DECISION MADE: 16-DEC-99
MEDFIELD, MA 02052                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DI
BAYER CORP.                       510(k) NO: K993711(TRADITIONAL)
ATTN: GABRIEL  MURACA             PHONE NO : 914-524-3494
511 BENEDICT AVE.                 SE DECISION MADE: 16-DEC-99
TARRYTOWN, NY 10591-5097          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/C
BECTON DICKINSON MICROBIOLOGY SYST510(k) NO: K993577(TRADITIONAL)
ATTN: MONICA E GIGUERE            PHONE NO : 410-316-4287
7 LOVETON CIR.                    SE DECISION MADE: 01-DEC-99
SPARKS, MD 21152-0999             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LA
BESGLOVE MEDICARE SDN. BHD.       510(k) NO: K993500(TRADITIONAL)
ATTN: LEE AIK  LIM                PHONE NO : 603 825 6361/2
LOT 6, JALAN P/2A                 SE DECISION MADE: 02-DEC-99
BANGI INDUSTRIAL ESTATE           510(k) STATEMENT
KAJANG,SELANGOR DARUL,EHASAN, MALAYSIA 43000

DEVICE: MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR
BIO-LOGIC SYSTEMS CORP.           510(k) NO: K994149(SPECIAL)
ATTN: NORMAN E BRUNNER            PHONE NO : 800-323-8326
ONE BIO-LOGIC PLAZA               SE DECISION MADE: 27-DEC-99
MUNDELEIN, IL 60060-3700          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIO-RAD HOMOCYSTEINE BY HPLC
BIO-RAD LABORATORIES, INC.        510(k) NO: K993107(TRADITIONAL)
ATTN: PATRICIA M KLIMLEY          PHONE NO : 510-741-6263
4000 ALFRED NOBEL DR.             SE DECISION MADE: 21-DEC-99
HERCULES, CA 94547                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
BIO-RESEARCH ASSOCIATES, INC.     510(k) NO: K991756(TRADITIONAL)
ATTN: LONNIE  WITHAM              PHONE NO : 219-267-6639
4113 NORTH PORT WASHINGTON RD.    SE DECISION MADE: 10-DEC-99
MILWAUKEE, WI 53212               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEI
BIOGRAFIK (MALAYSIA) SDN BHD      510(k) NO: K993529(TRADITIONAL)
ATTN: SHUKUR BIN  HASRAN          PHONE NO : 067 993 6453646449
PT 3307 JALAN AM 1                SE DECISION MADE: 29-DEC-99
ARAB-MALAYSIAN INDUSTRIAL PARK    510(k) SUMMARY AVAILABLE FROM FDA
NILAI, NEGERI SEMBILAN, MALAYSIA 71800

DEVICE: BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG
BIOMAGNETIC TECHNOLOGIES, INC.    510(k) NO: K993708(SPECIAL)
ATTN: EUGENE C HIRSCHKOFF         PHONE NO : 858-463-6300
9727 PACIFIC HEIGHTS BLVD.        SE DECISION MADE: 03-DEC-99
SAN DIEGO, CA 92121-3719          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: INTRAY GC
BIOMED DIAGNOSTICS, INC.          510(k) NO: K993033(TRADITIONAL)
ATTN: ROBERT D HALL               PHONE NO : 408-451-0400
1430 KOLL CIRCLE, SUITE 101       SE DECISION MADE: 16-DEC-99
SAN JOSE, CA 95112                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LACTOSORB TRAUMA PLATING SYSTEM
BIOMET, INC.                      510(k) NO: K992355(SPECIAL)
ATTN: TRACY J BICKEL              PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 20-DEC-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: TITANIUM PEDIATRIC FEMORAL NAIL
BIOMET, INC.                      510(k) NO: K993956(SPECIAL)
ATTN: LONNIE  WITHAM              PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 20-DEC-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46580

DEVICE: MODULAR REACH HIP
BIOMET, INC.                      510(k) NO: K994038(SPECIAL)
ATTN: FRED  MCCLURE               PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 22-DEC-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: BIONIKE AQ PHENCYCLIDINE (PCP) TEST
BIONIKE LABORATORIES, INC.        510(k) NO: K993945(TRADITIONAL)
ATTN: CLEVE W LAIRD               PHONE NO : 805-522-6223
1420 LOS ANGELES AVE              SE DECISION MADE: 07-DEC-99
SUITE 201                         510(k) SUMMARY AVAILABLE FROM FDA
SIMI VALLEY, CA 93065

DEVICE: SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 2
BIONX IMPLANTS, LTD.              510(k) NO: K993073(TRADITIONAL)
ATTN: TUIJA  ANNALA               PHONE NO : 358 331 65600
P.O. BOX 3                        SE DECISION MADE: 06-DEC-99
HERMINKATU 6-8L                   510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720

DEVICE: SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
BIONX IMPLANTS, LTD.              510(k) NO: K993074(TRADITIONAL)
ATTN: TUIJA  ANNALA               PHONE NO : 358 331 65600
P.O. BOX 3                        SE DECISION MADE: 10-DEC-99
HERMINKATU 6-8L                   510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720

DEVICE: MODIFICATION TO CARTO EP NAVIGATION SYSTEM
BIOSENSE WEBSTER, INC.            510(k) NO: K993729(SPECIAL)
ATTN: SANDRA  WILLIAMSON          PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD.           SE DECISION MADE: 03-DEC-99
DIAMOND BAR, CA 91765             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BIOTEQUE A.V. FISTULA NEEDLE SET
BIOTEQUE CORP.                    510(k) NO: K993118(TRADITIONAL)
ATTN: ALLEN  REICH                PHONE NO : 520-773-9488
900 N. SWITZER CANYON DR. #142    SE DECISION MADE: 17-DEC-99
FLAGGSTAFF, AZ 86001              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP
BIOTRONIK, INC.                   510(k) NO: K993139(TRADITIONAL)
ATTN: JON  BRUMBAUGH              PHONE NO : 888-345-0374
6024 JEAN RD.                     SE DECISION MADE: 17-DEC-99
LAKE OSWEGO, OR 97035-5369        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIRD V.I.P. GOLD/STERLING
BIRD PRODUCTS CORP.               510(k) NO: K993449(SPECIAL)
ATTN: DARRYL  SHELBY              PHONE NO : 800-232-7633
1100 BIRD CENTER DR.              SE DECISION MADE: 20-DEC-99
PALM SPRINGS, CA 92262            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MULTITAK SS
BONUTTI RESEARCH, INC.            510(k) NO: K993115(TRADITIONAL)
ATTN: PATRICK  BALSMANN           PHONE NO : 217-342-3412
2600 SOUTH RANEY                  SE DECISION MADE: 17-DEC-99
P.O. BOX 1367                     510(k) SUMMARY AVAILABLE FROM FDA
EFFINGHAM, IL 62401

DEVICE: WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTE
BOSTON SCIENTIFIC SCIMED, INC.    510(k) NO: K993232(TRADITIONAL)
ATTN: RONALD W BENNETT            PHONE NO : 612-694-5642
5905 NATHAN LANE                  SE DECISION MADE: 30-DEC-99
MINNEAPOLIS, MN 55442             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GUGLIELMI DETACHABLE (GDC)
BOSTON SCIENTIFIC, TARGET         510(k) NO: K991139(TRADITIONAL)
ATTN: JIM  LEATHLEY               PHONE NO : 510-440-7836
47900 BAYSIDE PARKWAY             SE DECISION MADE: 22-DEC-99
FREMONT, CA 94538                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BARDEX I.C. PEDIATRIC FOLEY CATHETER
C.R. BARD, INC.                   510(k) NO: K993464(ABBREVIATED)
ATTN: GEORGIA C ABERNATHY         PHONE NO : 770-784-6454
8195 INDUSTRIAL BLVD.             SE DECISION MADE: 10-DEC-99
COVINGTON, GA 30209               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG-7000DX ECG RECORDER/TRANSMITTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K993799(SPECIAL)
ATTN: LEONID  TRACHTENBERG        PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK       SE DECISION MADE: 10-DEC-99
REHOVOT, ISRAEL 76100             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CG-2100 ECG TRANSMITTER
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K994009(SPECIAL)
ATTN: LEONID  TRACHTENBERG        PHONE NO : 972 894 84600
2 PERERIS ST., SCIENCE PARK       SE DECISION MADE: 21-DEC-99
REHOVOT, ISRAEL 76100             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CARESIDE ANALYZER
CARESIDE, INC.                    510(k) NO: K993634(TRADITIONAL)
ATTN: KENNETH B ASARCH            PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY              SE DECISION MADE: 02-DEC-99
CULVER CITY, CA 90230             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESIDE DIRECT BILIRUBIN
CARESIDE, INC.                    510(k) NO: K993771(TRADITIONAL)
ATTN: KENNETH B ASARCH            PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY              SE DECISION MADE: 27-DEC-99
CULVER CITY, CA 90230             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FIRST RESPONSE 1-STEP PREGNANCY
CARTER-WALLACE, INC.              510(k) NO: K992232(TRADITIONAL)
ATTN: MAUREEN  GARNER             PHONE NO : 800-619-6344
HALF ACRE RD.                     SE DECISION MADE: 21-DEC-99
P.O. BOX 1001                     510(k) SUMMARY AVAILABLE FROM FDA
CRANBURY, NJ 08512

DEVICE: QMS MAPPING SYSTEM,MODEL 2000
CATHDATA INC.                     510(k) NO: K990058(TRADITIONAL)
ATTN: RICHARD  KEEN               PHONE NO : 203-329-2700
1151 HOPE STREET                  SE DECISION MADE: 15-DEC-99
STAMPFORD, CT 06907               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CATHETER INNOVATIONS IMPLANTABLE PORT
CATHETER INNOVATIONS, INC.        510(k) NO: K993860(SPECIAL)
ATTN: ROGER L RICHINS             PHONE NO : 801-954-8444
3598 WEST 1820 SOUTH              SE DECISION MADE: 03-DEC-99
SALT LAKE CITY, UT 84104-4859     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
CLINICAL DIAGNOSTIC SOLUTIONS, INC510(k) NO: K993375(ABBREVIATED)
ATTN: COLIN  ALDERSLEY            PHONE NO : 954-791-1773
1660 N.W. 65TH AVE., SUITE 2      SE DECISION MADE: 20-DEC-99
PLANTATION, FL 33313              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR
COBE CARDIOVASCULAR, INC.         510(k) NO: K993001(TRADITIONAL)
ATTN: LYNN  LEONARD               PHONE NO : 303-467-6586
14401 WEST 65TH WAY               SE DECISION MADE: 03-DEC-99
ARVADA, CO 80004                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
COGENT DIAGNOTICS LTD.            510(k) NO: K993304(TRADITIONAL)
ATTN: DANIELLE M KNIGHT           PHONE NO : 44 131 4457111
PENTLANDS SCIENCE PARK            SE DECISION MADE: 06-DEC-99
BUSH LOAN                         510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL

DEVICE: BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE
COLTENE/WHALEDENT INC.            510(k) NO: K993255(TRADITIONAL)
ATTN: H.J.  VOGELSTEIN            PHONE NO : 201-512-8000
750 CORPORATE DR.                 SE DECISION MADE: 06-DEC-99
MAHWAH, NJ 07430-2009             510(k) STATEMENT
 
DEVICE: MODIFICATION OF PARAPOST CEMENT
COLTENE/WHALEDENT INC.            510(k) NO: K993710(TRADITIONAL)
ATTN: H.J.  VOGELSTEIN            PHONE NO : 201-512-8000
750 CORPORATE DR.                 SE DECISION MADE: 21-DEC-99
MAHWAH, NJ 07430-2009             510(k) STATEMENT

DEVICE: PARAPOST SYSTEM STERILIZABLE ORGANIZER
COLTENE/WHALEDENT INC.            510(k) NO: K993835(TRADITIONAL)
ATTN: H.J.  VOGELSTEIN            PHONE NO : 201-512-8000
750 CORPORATE DR.                 SE DECISION MADE: 16-DEC-99
MAHWAH, NJ 07430-2009             510(k) STATEMENT

DEVICE: EMBOLIZATION COIL SYSTEM
COOK, INC.                        510(k) NO: K992121(TRADITIONAL)
ATTN: LISA  WEBB                  PHONE NO : 812-339-2235
925 S. CURRY PIKE                 SE DECISION MADE: 20-DEC-99
BLOOMINGTON, IN 47401             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP.                      510(k) NO: K994068(SPECIAL)
ATTN: ELENA  JUGO                 PHONE NO : 305-824-2332
14201 N.W. 60TH AVE.              SE DECISION MADE: 23-DEC-99
MIAMI LAKES, FL 33014             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
DADE BEHRING, INC.                510(k) NO: K993299(TRADITIONAL)
ATTN: RADAMES  RIESGO             PHONE NO : 305-636-7727
1851 DELAWARE PKWY.               SE DECISION MADE: 07-DEC-99
MIAMI, FL 33125                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICROSTREP PLUS PANEL
DADE MICROSCAN, INC.              510(k) NO: K983746(TRADITIONAL)
ATTN: SHAROLYN J LENTSCH          PHONE NO : 916-374-3183
1584 ENTERPRISE BLVD.             SE DECISION MADE: 09-DEC-99
WEST SACRAMENTO, CA 95691         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRIED GRAM-POSITIVE MIC/COMBO PANELS
DADE MICROSCAN, INC.              510(k) NO: K993102(TRADITIONAL)
ATTN: TREVOR  WALL                PHONE NO : 916-374-3332
1584 ENTERPRISE BLVD.             SE DECISION MADE: 02-DEC-99
WEST SACRAMENTO, CA 95691         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
DANEK MEDICAL, INC.               510(k) NO: K993855(SPECIAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PL.                  SE DECISION MADE: 15-DEC-99
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: TRIP TONOMETRY CATHETER, 14F
DATEX-OHMEDA, INC.                510(k) NO: K993296(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 978-640-0460
3 HIGHWOOD DR.                    SE DECISION MADE: 15-DEC-99
TEWKSBURY, MA 01876               510(k) STATEMENT

DEVICE: ENIGMA HI-BASE DENTURE BASE MATERIAL
DAVIS SCHOTTLANDER & DAVIS, LTD.  510(k) NO: K993717(TRADITIONAL)
ATTN: CLYDE E INGERSOLL           PHONE NO : 716-693-6591
54 RIVERVIEW AVE                  SE DECISION MADE: 22-DEC-99
TONAWANDA, NY 14150-5260          510(k) STATEMENT

DEVICE: MODIFICATION TO ISOLA SPINAL SYSTEM
DEPUY ACROMED                     510(k) NO: K993030(TRADITIONAL)
ATTN: FRANK  MAAS                 PHONE NO : 508-828-3390
325 PARAMOUNT DR.                 SE DECISION MADE: 29-DEC-99
RAYNHAM, MA 02767                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BREMER HALO SYSTEM TITANIUM SKULL PIN
DEPUY ACROMED                     510(k) NO: K993099(TRADITIONAL)
ATTN: FRANK  MASS                 PHONE NO : 508-828-3390
325 PARAMOUNT DR.                 SE DECISION MADE: 15-DEC-99
RAYNHAM, MA 02767                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
DIAGNOSTIC PRODUCTS CORP.         510(k) NO: K993952(SPECIAL)
ATTN: EDWARD M LEVINE             PHONE NO : 310-645-8200
5700 WEST 96TH ST.                SE DECISION MADE: 16-DEC-99
LOS ANGELES, CA 90045             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
DIASORIN INC.                     510(k) NO: K992552(TRADITIONAL)
ATTN: JUDITH J SMITH              PHONE NO : 301-497-0005
9175 GUIFORD ROAD                 SE DECISION MADE: 16-DEC-99
COLUMBIA, MD 21046                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
DIASORIN/AMERICAN STANDARD COMPANI510(k) NO: K994110(SPECIAL)
ATTN: JUDITH J SMITH              PHONE NO : 301-497-0005
9175 GUILFORD RD., SUITE 100      SE DECISION MADE: 21-DEC-99
QUARRY PARK PLACE                 510(k) SUMMARY AVAILABLE FROM FDA
COLUMBIA, MD 21046

DEVICE: DIGITEC TWO STAGE COMPRESSION KIT
DIGITEC MEDICAL SERVICE CORPORATIO510(k) NO: K993681(TRADITIONAL)
ATTN: JAMES J MCGINITY            PHONE NO : 770-995-0050
465 MALTBIE STREET                SE DECISION MADE: 21-DEC-99
SUITE 407                         510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCEVILLE, GA 30045

DEVICE: DISETRONIC D-TRON INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS        510(k) NO: K994186(SPECIAL)
ATTN: LEE  LEICHTER               PHONE NO : 941-768-1118
7690 CAMERON CIRCLE               SE DECISION MADE: 30-DEC-99
FORT MYERS, FL 33912              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISENTRONIC PENFINE INJECTION PEN NEEDLE
DISETRONIC MEDICAL SYSTEMS        510(k) NO: K994197(SPECIAL)
ATTN: LEE  LEICHTER               PHONE NO : 941-768-1118
7690 CAMERON CIRCLE               SE DECISION MADE: 29-DEC-99
FORT MYERS, FL 33912              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200
DOCTOR'S RESEARCH GROUP, INC.     510(k) NO: K991714(TRADITIONAL)
ATTN: RICHARD  DESLAURIERS        PHONE NO : 203-879-9422
143 WOLCOTT RD.                   SE DECISION MADE: 10-DEC-99
WOLCOTT, CT                       510(k) STATEMENT

DEVICE: CUSTODIOL
DR. FRANZ KOHLER CHEMIE GMBH      510(k) NO: K992209(TRADITIONAL)
ATTN: T. WHIT  ATHEY              PHONE NO : 301-770-9590
12300 TWINBROOK PARKWAY           SE DECISION MADE: 10-DEC-99
SUITE 625                         510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852

DEVICE: SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
DRUG DETECTION DEVICES, LTD.      510(k) NO: K992949(TRADITIONAL)
ATTN: BRUCE  CHRISTIE             PHONE NO : 770-886-6226
6820 MEADOWRIDGE COURT            SE DECISION MADE: 27-DEC-99
SUITE A-7                         510(k) SUMMARY AVAILABLE FROM FDA
ALPHARETTA, GA 30005

DEVICE: ETHYL CHLORIDE DISPENSER
DUKAL CORP.                       510(k) NO: K984564(TRADITIONAL)
ATTN: ED  RASOM                   PHONE NO : 813-376-4154
3234 ELLA LANE                    SE DECISION MADE: 02-DEC-99
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
EBI, L.P.                         510(k) NO: K993822(SPECIAL)
ATTN: PATRICIA  FLOOD             PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 10-DEC-99
PARSIPPANY, NJ 07054-1079         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBI XFIX VISION FIXATION SYSTEM
EBI, L.P.                         510(k) NO: K993886(SPECIAL)
ATTN: JON  CAPAROTTA              PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 14-DEC-99
PARSIPPANY, NJ 07054-1079         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENSITE 3000 SYSTEM
ENDOCARDIAL SOLUTIONS, INC.       510(k) NO: K992479(TRADITIONAL)
ATTN: JAMES W BULLOCK             PHONE NO : 651-523-6928
1350 ENERGY LN., SUITE 110        SE DECISION MADE: 02-DEC-99
ST. PAUL, MN 55108                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAT-SHELL DISPOSABLE SPO2 SENSOR
EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K992092(TRADITIONAL)
ATTN: KRISTA  OAKES               PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300          SE DECISION MADE: 22-DEC-99
PLANO, TX 75074                   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SPO2 WRAP SENSOR
EPIC MEDICAL EQUIPMENT SERVICES IN510(k) NO: K992211(TRADITIONAL)
ATTN: KRISTA  OAKES               PHONE NO : 972-801-9854
1800 10TH ST., SUITE 300          SE DECISION MADE: 22-DEC-99
PLANO, TX 75074                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PROMPTFLOW
ESPE DENTAL AG                    510(k) NO: K993566(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 011 498 1527001395
ESPE PLATZ                        SE DECISION MADE: 06-DEC-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5,
ETHICON ENDO-SURGERY, INC.        510(k) NO: K993054(TRADITIONAL)
ATTN: RUTH ANN  WOOD              PHONE NO : 513-483-3468
4545 CREEK RD.                    SE DECISION MADE: 09-DEC-99
CINCINNATI, OH 45242-2839         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: "POLLER CALIBRANTS"
EUROPEAN CONCERTED ACTION ON ANTIC510(k) NO: K991439(TRADITIONAL)
ATTN: L.  POLLER                  PHONE NO : 441 612 755516
OXFORD ROAD                       SE DECISION MADE: 20-DEC-99
MANCHESTER, UNITED KINGDOM M13 9PT510(k) STATEMENT

DEVICE: POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN L
FELDA RUBBER CORP.                510(k) NO: K993820(TRADITIONAL)
ATTN: YUNUS  LATIF                PHONE NO : 03 292 3033
TINGKAT 7, BALAI FELDA            SE DECISION MADE: 02-DEC-99
JALAN GURNEY 1                    510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 54000

DEVICE: LATEX SURGICAL GLOVES, PRE-POWDERED
FITCO DIPPED PRODUCTS PVT. LTD    510(k) NO: K993450(TRADITIONAL)
ATTN: JOSEPH  PEREIRA             PHONE NO : 910 484 424033
14-A COCHIN EXPORT PROCESSING     SE DECISION MADE: 29-DEC-99
ZONE, KAKKANAND, COCHIN           510(k) SUMMARY AVAILABLE FROM FDA
KERALA, INDIA 682 030

DEVICE: FRIALIT-2 SELECT COMPONENTS
FRIADENT GMBH                     510(k) NO: K993095(TRADITIONAL)
ATTN: CAROL  PATTERSON            PHONE NO : 949-462-0900
21911 ERIE LANE                   SE DECISION MADE: 09-DEC-99
LAKE FOREST, CA 92630             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
GE MEDICAL SYSTEMS, INC.          510(k) NO: K993645(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 414-544-3894
P.O. BOX 414                      SE DECISION MADE: 21-DEC-99
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K994075(TRADITIONAL)
ATTN: JOHN  BOTTJER               PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195     SE DECISION MADE: 27-DEC-99
MONARCH BEACH, CA 92629           510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: EIM-107 PREP-CHECK
GENERAL DEVICES                   510(k) NO: K993202(TRADITIONAL)
ATTN: MICHAEL  SMITH              PHONE NO : 201-313-7075
1000 RIVER ST.                    SE DECISION MADE: 17-DEC-99
RIDGEFIELD, NJ 07657              510(k) STATEMENT

DEVICE: GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PR
GLOVCO (M) SDN. BHD.              510(k) NO: K993752(TRADITIONAL)
ATTN: TAN PENG  HOCK              PHONE NO : 603 391 13888
LOT 760, JALAN HAJI SIRAT,        SE DECISION MADE: 03-DEC-99
OFF JALAN MERU                    510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100

DEVICE: MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
GLOVESWORLD INDUSTRIES SDN. BHD.  510(k) NO: K993127(TRADITIONAL)
ATTN: BIEN LONG  NIEN             PHONE NO : 603 816 7567/7568
LOT P.T. 153, KAWASAN             SE DECISION MADE: 02-DEC-99
PERUSAHAAN BERANANG, MUKIM        510(k) STATEMENT
BERANANG, SELANGOR, D.E., MALAYSIA 43700

DEVICE: GRADILEIDEN V TEST
GRADIPORE LTD.                    510(k) NO: K992456(TRADITIONAL)
ATTN: RHONDA  PILGRIM             PHONE NO : 800 762 2620
LOT16 RIVERSIDE CORPORATE PARK    SE DECISION MADE: 21-DEC-99
35-105 DELHI ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
NORTH RYDE, AUSTRALIA NSW 2113

DEVICE: LATEX EXAMINATION POWDERED GLOVES
GREAT GLOVE SDN BHD               510(k) NO: K993386(TRADITIONAL)
ATTN: K.M.  LEE                   PHONE NO : 603 350 0646
24, JALAN MOKHTAR DUA             SE DECISION MADE: 20-DEC-99
KAPAR, SELANGOR D.E., MALAYSIA 422510(k) STATEMENT

DEVICE: FASTSEAL CHEST WOUND DRESSING
GREENFIELD MEDICAL TECHNOLOGIES, I510(k) NO: K990079(TRADITIONAL)
ATTN: DONALD R GORSUCH            PHONE NO : 508-393-7907
40 VALENTINE ROAD                 SE DECISION MADE: 23-DEC-99
NORTHBOROUGH, MA 01532            510(k) STATEMENT

DEVICE: EIS THREADED SCREW FRACTURE FIXATION
GROUPE LEPINE                     510(k) NO: K991964(TRADITIONAL)
ATTN: DOUGLAS W STUART            PHONE NO : 941-366-1882
962 SOUTH TAMIAMI TRAIL           SE DECISION MADE: 20-DEC-99
SUITE 203                         510(k) STATEMENT
SARASOTA, FL 34326

DEVICE: GYRUS HYSTEROSCOPIC RESECTOSCOPE
GYRUS MEDICAL LTD.                510(k) NO: K993749(SPECIAL)
ATTN: DAVID  KAY                  PHONE NO : 440 122 2300100
FORTRAN RD., ST. MELLONS          SE DECISION MADE: 03-DEC-99
CARDIFF, UNITED KINGDOM CF3 0LT   510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
GYRUS MEDICAL LTD.                510(k) NO: K994166(SPECIAL)
ATTN: DAVID  KAY                  PHONE NO : 440 122 23000100
FORTRAN RD., ST. MELLONS          SE DECISION MADE: 27-DEC-99
CARDIFF, UNITED KINGDOM CF3 0LT   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPO
HARDY DIAGNOSTICS                 510(k) NO: K993812(TRADITIONAL)
ATTN: MELISSA M TAYLOR            PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 21-DEC-99
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK AMIKACIN 30MCG
HARDY DIAGNOSTICS                 510(k) NO: K993993(TRADITIONAL)
ATTN: MELISSA M TRAYLOR, RAC      PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 27-DEC-99
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: HARDYDISK AZITHROMYCIN 15MCG
HARDY DIAGNOSTICS                 510(k) NO: K993994(TRADITIONAL)
ATTN: MELISSA M TRAYLOR           PHONE NO : 805-346-2766
1430 WEST MCCOY LANE              SE DECISION MADE: 21-DEC-99
SANTA MARIA, CA 93455             510(k) STATEMENT

DEVICE: LC COMPOSITE
HARRY J. BOSWORTH CO.             510(k) NO: K991492(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN         PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE.            SE DECISION MADE: 02-DEC-99
SKOKIE, IL 60076                  510(k) STATEMENT

DEVICE: PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
HARRY J. BOSWORTH CO.             510(k) NO: K993716(TRADITIONAL)
ATTN: MILDRED M GOLDSTEIN         PHONE NO : 847-679-3400
7227 NORTH HAMLIN AVE.            SE DECISION MADE: 21-DEC-99
SKOKIE, IL 60076                  510(k) STATEMENT

DEVICE: HL148 & HL168
HEALTH & LIFE CO., LTD.           510(k) NO: K990807(TRADITIONAL)
ATTN: SUSAN  CHEN                 PHONE NO : 886 232 349600
4F-3, NO. 351, CHUNG SHAM RD.     SE DECISION MADE: 03-DEC-99
SEC.02, CHUNG HO CITY             510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)

DEVICE: HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
HELAX AB                          510(k) NO: K993766(SPECIAL)
ATTN: E.S.  MARTELL               PHONE NO : 011 461 85655000
447 MARCH ROAD                    SE DECISION MADE: 08-DEC-99
KANATA ONTARIO, CANADA K2K 1X8    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THERMOCHEM-HT SYSTEM
HEMOCLEANSE, INC.                 510(k) NO: K993330(TRADITIONAL)
ATTN: STEPHEN R ASH               PHONE NO : 765-463-9540
2700 KENT AVE.                    SE DECISION MADE: 30-DEC-99
WEST LAFAYETTE, IN 47906          510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PRE-VISION FILL
HERAEUS KULZER, INC.              510(k) NO: K993602(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN          PHONE NO : 219-299-6662
4315 SOUTH LAFAYETTE BLVD.        SE DECISION MADE: 15-DEC-99
SOUTH BEND, IN 46614-2517         510(k) STATEMENT

DEVICE: SOLITAIRE 2
HERAEUS KULZER, INC.              510(k) NO: K993932(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN          PHONE NO : 219-291-0661
4315 S. LAFAYETTE BLVD.           SE DECISION MADE: 22-DEC-99
SOUTH BEND, IN 46530              510(k) STATEMENT

DEVICE: HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3
HEWLETT-PACKARD CO.               510(k) NO: K992977(TRADITIONAL)
ATTN: WARREN R WALTERS            PHONE NO : 515-244-1212
2500 BELL AVE.                    SE DECISION MADE: 01-DEC-99
DES MOINES, IA 50321              510(k) STATEMENT

DEVICE: MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER,
HEWLETT-PACKARD CO.               510(k) NO: K993169(TRADITIONAL)
ATTN: SHEILA W PICKERING, PHD.    PHONE NO : 650-969-6114
2081 LONGDEN CIRCLE               SE DECISION MADE: 20-DEC-99
LOS ALTOS, CA 94024               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-S
HEWLETT-PACKARD GMBH              510(k) NO: K992595(SPECIAL)
ATTN: EGON  PFEIL                 PHONE NO : 703-114-2243
HERRENBERGER STR. 110-140         SE DECISION MADE: 08-DEC-99
BOEBLINGEN, GERMANY 71034         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
HOWMEDICA OSTEONICS CORP.         510(k) NO: K990849(TRADITIONAL)
ATTN: MARYBETH  NAUGHTON          PHONE NO : 201-934-4376
359 VETERANS BLVD.                SE DECISION MADE: 20-DEC-99
RUTHERFORD, NJ 07070-2584         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPUS SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K993402(TRADITIONAL)
ATTN: MARY-CATHERINE  DILLON      PHONE NO : 201-760-8117
59 ROUTE 17                       SE DECISION MADE: 20-DEC-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURACON INSET PATELLA, 25MM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K993692(SPECIAL)
ATTN: TERRY  SHERIDAN POWELL      PHONE NO : 201-934-4375
59 ROUTE 17                       SE DECISION MADE: 02-DEC-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACTIFRESH 400 LENS
HYDRON LTD.                       510(k) NO: K983637(TRADITIONAL)
ATTN: JULIAN B HOLLOWAY           PHONE NO : 011 441 252554500
HAWLEY LANE                       SE DECISION MADE: 10-DEC-99
FARNBOROUGH, HANTS, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SNN FLUORO NAVIGATION SYSTEM
I.S.G. TECHNOLOGIES, INC.         510(k) NO: K993673(TRADITIONAL)
ATTN: DOLORES  MCGIRR             PHONE NO : 905 672 2100
6509 AIRPORT RD.                  SE DECISION MADE: 21-DEC-99
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
IBM ISRAEL LTD.                   510(k) NO: K993338(TRADITIONAL)
ATTN: ELI M ORBACH                PHONE NO : 972 299 32768
P.O. BOX 6718                     SE DECISION MADE: 29-DEC-99
EFRAT, ISRAEL 90435               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BI
IMAGYN SURGICAL                   510(k) NO: K993936(TRADITIONAL)
ATTN: JULIE  POWELL               PHONE NO : 616-629-5811
8850 M-89                         SE DECISION MADE: 27-DEC-99
RICHLAND, MI 49083                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COLON ALERT TEST
IMMUNOSTICS, INC.                 510(k) NO: K992759(TRADITIONAL)
ATTN: VINCENT P LASTELLA          PHONE NO : 732-918-0770
3505 SUNSET AVE.                  SE DECISION MADE: 06-DEC-99
OCEAN, NJ 07712                   510(k) STATEMENT

DEVICE: DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3
IMPAX TECHNOLOGY INC.             510(k) NO: K993532(TRADITIONAL)
ATTN: PAULA  PFEIFLE              PHONE NO : 519 746 2900
455 PHILLIP ST.                   SE DECISION MADE: 15-DEC-99
WATERLOO, ONTARIO, CANADA N2L 3X2 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVIGRA
INDUS MEDICARE LTD.               510(k) NO: K993693(ABBREVIATED)
ATTN: P.K.  REDDY                 PHONE NO : 91 40 7760241
144, S.P. RD., BEGUMPET           SE DECISION MADE: 29-DEC-99
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT

DEVICE: INNOVAQUARTZ GENERAL SHAPE LASER FIBER
INNNOVAQUARTZ INC.                510(k) NO: K994010(TRADITIONAL)
ATTN: RANDY  MCLELLAN             PHONE NO : 602-268-4930
4420 SOUTH 32ND ST.               SE DECISION MADE: 17-DEC-99
PHOENIX, AZ 85040                 510(k) STATEMENT

DEVICE: ABSOLUTE ABSORBABLE INTERFERENCE SCREW
INNOVASIVE DEVICES, INC.          510(k) NO: K993975(SPECIAL)
ATTN: KATHLEEN  MORAHAN           PHONE NO : 508-460-8229
734 FOREST ST.                    SE DECISION MADE: 20-DEC-99
MARLBOROUGH, MA 01752             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,
INTERPORE CROSS INTL.             510(k) NO: K993808(SPECIAL)
ATTN: PROSIE  REY-FESSLER         PHONE NO : 949-453-3200
181 TECHNOLOGY DR.                SE DECISION MADE: 06-DEC-99
IRVINE, CA 92618-2402             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
INTRACEL CORP.                    510(k) NO: K991074(TRADITIONAL)
ATTN: SHERYL  RUPPEL              PHONE NO : 301-258-5200
1330 PICCARD DR.                  SE DECISION MADE: 21-DEC-99
ROCKVILLE, MD 20850-4396          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRALASE 600C LASER KERATOME
INTRALASE CORPORATION             510(k) NO: K993153(TRADITIONAL)
ATTN: JUDY F GORDON               PHONE NO : 949-854-6314
18732 SAGINAW                     SE DECISION MADE: 17-DEC-99
IRVINE, CA 92612                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE C
INVACARE CORP.                    510(k) NO: K993413(TRADITIONAL)
ATTN: EDWAED A KROLL              PHONE NO : 440-329-6595
ONE INVACARE WAY                  SE DECISION MADE: 15-DEC-99
P.O. BOX 4028                     510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036

DEVICE: IRIDERM, MODEL APEX 800
IRIDEX CORP.                      510(k) NO: K992298(TRADITIONAL)
ATTN: BRAD  RENTON                PHONE NO : 650-962-8100
1212 TERRA BELLA AVE.             SE DECISION MADE: 09-DEC-99
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LUMA-CATH STEERABLE EP CATHETERS
IRVINE BIOMEDICAL, INC.           510(k) NO: K991878(TRADITIONAL)
ATTN: ROGER  TU                   PHONE NO : 949-851-3053
2146-A MICHELSON DR.              SE DECISION MADE: 10-DEC-99
IRVINE, CA 92612                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TYRODE'S SOLUTION-ACIDIFIED
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K991339(TRADITIONAL)
ATTN: ROBERTA L JOHNSON           PHONE NO : 800-437-5706
2511 DAIMLER ST.                  SE DECISION MADE: 06-DEC-99
SANTA ANA, CA 92705               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TETRIC FLOW
IVOCLAR NORTH AMERICA, INC.       510(k) NO: K993783(TRADITIONAL)
ATTN: PETER P MANCUSO             PHONE NO : 716-691-0010
175 PINEVIEW DR.                  SE DECISION MADE: 13-DEC-99
AMHERST, NY 14228                 510(k) STATEMENT

DEVICE: K-ASSAY FIBRINOGEN
KAMIYA BIOMEDICAL CO.             510(k) NO: K993482(TRADITIONAL)
ATTN: COLIN  GETTY                PHONE NO : 206-575-8068
910 INDUSTRY DR.                  SE DECISION MADE: 06-DEC-99
SEATTLE, WA 98188-3412            510(k) STATEMENT

DEVICE: K-ASSAY MULTI-ANALYTE CALIBRATOR
KAMIYA BIOMEDICAL CO.             510(k) NO: K993853(TRADITIONAL)
ATTN: COLIN  GETTY                PHONE NO : 206-575-8068
910 INDUSTRY DR.                  SE DECISION MADE: 27-DEC-99
SEATTLE, WA 98188-3412            510(k) STATEMENT
 
DEVICE: DCI ENDOSCOPE
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K993539(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 15-DEC-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KEELER CRYO MASTER & PROBES
KEELER INSTRUMENTS, INC.          510(k) NO: K992954(TRADITIONAL)
ATTN: EUGENE R VAN ARSDALE        PHONE NO : 800-523-5620
456 PARKWAY                       SE DECISION MADE: 21-DEC-99
BROOMALL, PA 19008                510(k) STATEMENT

DEVICE: KLS-MARTIN MMF SCREW
KLS-MARTIN L.P.                   510(k) NO: K980760(TRADITIONAL)
ATTN: PATRICK J LAMB              PHONE NO : 813-376-4154
3234 ELLA LANE                    SE DECISION MADE: 21-DEC-99
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
LAERDAL MEDICAL A/S               510(k) NO: K993668(TRADITIONAL)
ATTN: MAGNE  STEINSET             PHONE NO : 47 515 11700
TANKE SVILANDSGT. 30              SE DECISION MADE: 20-DEC-99
STAVANGER, NORWAY N 4001          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONIT
LIFESTREAM TECHNOLOGIES, INC.     510(k) NO: K993096(TRADITIONAL)
ATTN: JACKSON B CONNOLLY          PHONE NO : 208-457-9409
51O CLEARWATER LOOP, SUITE 101    SE DECISION MADE: 20-DEC-99
POST FALLS, ID 83854              510(k) STATEMENT

DEVICE: ENDOPEARL WITH THREADER
LINVATEC CORP.                    510(k) NO: K993339(TRADITIONAL)
ATTN: LAURA  SENEFF               PHONE NO : 727-392-6464
11311 CONCEPT BLVD.               SE DECISION MADE: 10-DEC-99
LARGO, FL 33773-4908              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: M-PACT CORNEAL LIGHT SHIELD
M-PACT CORP.                      510(k) NO: K993883(TRADITIONAL)
ATTN: AL  BOEDEKER                PHONE NO : 785-542-2920
1040 0CL PARKWAY,                 SE DECISION MADE: 21-DEC-99
EUDORA, KS                        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
MAERSK MEDICAL A/S                510(k) NO: K990110(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST                 SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
MAERSK MEDICAL A/S                510(k) NO: K990111(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST                 SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
MAERSK MEDICAL A/S                510(k) NO: K990112(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST                 SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 45
MAERSK MEDICAL A/S                510(k) NO: K990113(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST                 SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
MAERSK MEDICAL A/S                510(k) NO: K990115(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST                 SE DECISION MADE: 06-DEC-99
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONI
MAGNETIC RESONANCE EQUIPMENT CORP.510(k) NO: K983250(TRADITIONAL)
ATTN: G.RONALD  MORRIS            PHONE NO : 516-243-3500
6 WASHINGTON AVE.                 SE DECISION MADE: 12-DEC-99
BAY SHORE, NY 11706               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPTISTAR MR INJECTOR SYSTEM
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K984088(TRADITIONAL)
ATTN: BRIDGET  DRAKE              PHONE NO : 800-347-9730
2111 EAST GALBRAITH RD.           SE DECISION MADE: 06-DEC-99
P.O. BOX 156305                   510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45215-6305

DEVICE: QUANTITATIVE SENTINEL SYSTEM
MARQUETTE MEDICAL SYSTEMS, INC.   510(k) NO: K993008(TRADITIONAL)
ATTN: MARIA  VITUG FOUTS          PHONE NO : 800-851-6525
200 HARRY SOUTH TRUMAN PKWY.      SE DECISION MADE: 06-DEC-99
SUITE 220                         510(k) SUMMARY AVAILABLE FROM FDA
ANNAPOLIS, MD 21401

DEVICE: CERADIUM V NON-PRECIOUS CERAMIC ALLOY
MATECH, INC.                      510(k) NO: K993572(TRADITIONAL)
ATTN: PAUL L SAXTON               PHONE NO : 818-367-2472
13010 SAN FERNANDO RD.            SE DECISION MADE: 13-DEC-99
SYLMAR, CA 91342                  510(k) STATEMENT

DEVICE: SYSTEM 2100
MATH SOLUTIONS, LLC               510(k) NO: K993530(TRADITIONAL)
ATTN: WENDEL DEAN  RENNER         PHONE NO : 410-997-9578
5975 GALES LANE                   SE DECISION MADE: 15-DEC-99
COLUMBIA, MD 21045                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATHFINDER II ANGIOGRAPHIC CATHETER
MAXXIM MEDICAL                    510(k) NO: K990173(TRADITIONAL)
ATTN: EDDIE  MONROE               PHONE NO : 903-675-9321
1445 FLAT CREEK RD.               SE DECISION MADE: 21-DEC-99
ATHENS, TX 75751                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: CADENCE DOPPLER ULTRASOUND SYSTEM
MEDASONICS, INC.                  510(k) NO: K991441(TRADITIONAL)
ATTN: WILLIAM E MCKAY             PHONE NO : 801-944-9977
9712 S. ALTAMONT DRIVE            SE DECISION MADE: 28-DEC-99
SANDY, UT 84092                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIT ENHANCER
MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K992943(TRADITIONAL)
ATTN: LINDA M UPTON               PHONE NO : 510-357-3952
14477 CATALINA ST.                SE DECISION MADE: 10-DEC-99
SAN LEANDRO, CA 94577             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
MEDIPACK - MEDICAL PACKAGING MFG. 510(k) NO: K993764(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301-519-1098
9109 COPENHAVER DRIVE             SE DECISION MADE: 16-DEC-99
POTOMAC, MD 20854                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K993761(TRADITIONAL)
ATTN: DOUGLAS F ORR               PHONE NO : 203-438-5588
109 DANBURY ROAD                  SE DECISION MADE: 28-DEC-99
RIDGEFIELD, CT 06877              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VERDICT -II OPIATES 2000
MEDTOX DIAGNOSTICS, INC.          510(k) NO: K992111(TRADITIONAL)
ATTN: MICHAEL  TURANCHIK          PHONE NO : 336-226-6311
1238 ANTHONY RD.                  SE DECISION MADE: 16-DEC-99
BURLINGTON, NC 27215              510(k) STATEMENT

DEVICE: MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006
MEMCATH TECHNOLOGIES LLC          510(k) NO: K993226(TRADITIONAL)
ATTN: MARC  JAKER                 PHONE NO : 651-450-7400
1777 OAKDALE AVENUE               SE DECISION MADE: 10-DEC-99
WEST ST. PAUL, MN 55118-4031      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MENTOR EVACARE VAGINAL PESSARIES
MENTOR CORP.                      510(k) NO: K993308(TRADITIONAL)
ATTN: DONNA A CRAWFORD            PHONE NO : 805-879-6304
201 MENTOR DRIVE                  SE DECISION MADE: 13-DEC-99
SANTA BARBARA, CA 93111           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PREMIER TOXINS A&B, MODEL 616096
MERIDIAN DIAGNOSTICS, INC.        510(k) NO: K993914(SPECIAL)
ATTN: DAVID H WILLIS              PHONE NO : 513-271-3700
3471 RIVER HILLS DR.              SE DECISION MADE: 10-DEC-99
CINCINNATI, OH 45244              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELTAPAL, ALLOY NO. 5161
METALOR DENTAL USA CORP.          510(k) NO: K993474(TRADITIONAL)
ATTN: KENNETH A PUTNEY            PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD.         SE DECISION MADE: 02-DEC-99
NORTH ATTLEBOROUGH, MA 02761      510(k) STATEMENT
 
DEVICE: AUROFLUID M, ALLOY NO. 5315
METALOR DENTAL USA CORP.          510(k) NO: K993475(TRADITIONAL)
ATTN: KENNETH A PUTNEY            PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD.         SE DECISION MADE: 09-DEC-99
NORTH ATTLEBOROUGH, MA 02761      510(k) STATEMENT

DEVICE: V-DELTA SPECIAL, ALLOY NO. 5154
METALOR DENTAL USA CORP.          510(k) NO: K993505(TRADITIONAL)
ATTN: KENNITH A PUTNEY            PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD.         SE DECISION MADE: 08-DEC-99
P.O. BOX 255                      510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761

DEVICE: PAGALINOR 4 , ALLOY NO. 5440
METALOR DENTAL USA CORP.          510(k) NO: K993506(TRADITIONAL)
ATTN: KENNETH A PUTNEY            PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD.         SE DECISION MADE: 08-DEC-99
P.O. BOX 255                      510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761

DEVICE: V-SUPRAGOLD, ALLOY NO. 5024
METALOR DENTAL USA CORP.          510(k) NO: K993507(TRADITIONAL)
ATTN: KENNETH A PUTNEY            PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD.         SE DECISION MADE: 06-DEC-99
P.O. BOX 255                      510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761

DEVICE: V-SUPRA PLUS, ALLOY NO. 5025
METALOR DENTAL USA CORP.          510(k) NO: K993508(TRADITIONAL)
ATTN: KENNETH A PUTNEY            PHONE NO : 508-695-8143
255 JOHN L. DIETSCH BLVD.         SE DECISION MADE: 06-DEC-99
P.O. BOX 255                      510(k) STATEMENT
NORTH ATTLEBOROUGH, MA 02761

DEVICE: VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
METRON MEDICAL AUSTRALIA P/L      510(k) NO: K993821(SPECIAL)
ATTN: R.H.  HOPKINS               PHONE NO : 03 977 51234
57 ASTER AVE.                     SE DECISION MADE: 09-DEC-99
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT

DEVICE: TALON ANCHOR SNAP-PAK
MITEK PRODUCTS                    510(k) NO: K993261(TRADITIONAL)
ATTN: PAULA A BULGER              PHONE NO : 781-251-2746
60 GLACIER DR.                    SE DECISION MADE: 02-DEC-99
WESTWOOD, MA 02090                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TALON ANCHOR SNAP-PAK
MITEK PRODUCTS                    510(k) NO: K993327(TRADITIONAL)
ATTN: PAULA E BULGER              PHONE NO : 781-251-2746
60 GLACIER DR.                    SE DECISION MADE: 16-DEC-99
WESTWOOD, MA 02090                510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RESOLVE QUICKANCHOR
MITEK PRODUCTS                    510(k) NO: K993575(TRADITIONAL)
ATTN: PAULA E BULGER              PHONE NO : 781-251-2746
60 GLACIER DR.                    SE DECISION MADE: 29-DEC-99
WESTWOOD, MA 02090                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK
MORAX                             510(k) NO: K992148(TRADITIONAL)
ATTN: BOREK  JANIK                PHONE NO : 734-475-2441
13805 WATERLOO ROAD               SE DECISION MADE: 29-DEC-99
CHELSEA, MI 48118                 510(k) STATEMENT

DEVICE: OBC-300 BREAST ARRAY COIL
MRI DEVICES CORP.                 510(k) NO: K993776(SPECIAL)
ATTN: THOMAS  SCHUBERT            PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K     SE DECISION MADE: 03-DEC-99
JOHNSON DR., CORPORATE CENTER     510(k) STATEMENT
WAUKESHA, WI 53186

DEVICE: QWH-300 WRIST ARRAY COIL
MRI DEVICES CORP.                 510(k) NO: K993819(SPECIAL)
ATTN: THOMAS  SCHUBERT            PHONE NO : 414-524-1402
N8 W22520 JOHNSON DR., UNIT K     SE DECISION MADE: 03-DEC-99
JOHNSON DR., CORPORATE CENTER     510(k) STATEMENT
WAUKESHA, WI 53186

DEVICE: AED ARTHROSCOPE
NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K991656(TRADITIONAL)
ATTN: GAYLE M BUTLER              PHONE NO : 310-446-4600
10801 NATIONAL BLVD., #603        SE DECISION MADE: 02-DEC-99
LOS ANGELES, CA 90064             510(k) STATEMENT

DEVICE: AED LAPAROSCOPE
NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K993688(TRADITIONAL)
ATTN: GAYLE M BUTLER              PHONE NO : 310-446-4600
10801 NATIONAL BLVD., #603        SE DECISION MADE: 06-DEC-99
LOS ANGELES, CA 90064             510(k) STATEMENT

DEVICE: AED CYSTOSCOPE
NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K993689(TRADITIONAL)
ATTN: GAYLE M BUTLER              PHONE NO : 310-446-4600
10801 NATIONAL BLVD., #603        SE DECISION MADE: 15-DEC-99
LOS ANGELES, CA 90064             510(k) STATEMENT

DEVICE: ULTRA-GARMENT ELECTRODE
NEWWAVE MEDICAL LLC               510(k) NO: K993130(TRADITIONAL)
ATTN: ROBERT  ARMSTRONG           PHONE NO : 972-396-5400
1538 HAVEN PLACE                  SE DECISION MADE: 17-DEC-99
ALLEN, TX 75002                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
NEXAN TELEMED LTD.                510(k) NO: K993643(TRADITIONAL)
ATTN: KENNETH  PALMER             PHONE NO : 301-548-0508
15825 SHADY GROVE ROAD            SE DECISION MADE: 28-DEC-99
SUITE 130                         510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20850-4008
 
DEVICE: NEXFLEX TOTAL KNEE SYSTEM
NEXMED, INC.                      510(k) NO: K991882(TRADITIONAL)
ATTN: JASON  BLAIN                PHONE NO : 760-779-8250
42-160 STATE ST., SUITE B         SE DECISION MADE: 08-DEC-99
PALM DESERT, CA 92211             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR
NICHOLS INSTITUTE DIAGNOSTICS     510(k) NO: K992188(TRADITIONAL)
ATTN: JAMES A RYBSKI              PHONE NO : 949-240-5260
33051 CALLE AVIADOR               SE DECISION MADE: 06-DEC-99
SAN JUAN CAPISTRANO, CA 92675     510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181
NIHON SEIMITSU SOKKI CO., LTD.    510(k) NO: K993890(TRADITIONAL)
ATTN: ROBERT D WAXHAM             PHONE NO : 757-365-0978
222 INSTITUTE ST.                 SE DECISION MADE: 01-DEC-99
SMITHFIELD, VA 23430              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAPTOR TREATMENT PLANNING SYSTEM
NOMOS CORP.                       510(k) NO: K993359(TRADITIONAL)
ATTN: WILLIAM O CHISHKO           PHONE NO : 724-934-8200
2591 WEXFORD BAYNE RD., #400      SE DECISION MADE: 21-DEC-99
SEWICKLEY, PA 15143               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROL
NOVA BIOMEDICAL CORP.             510(k) NO: K993104(TRADITIONAL)
ATTN: PAUL W MAC DONALD           PHONE NO : 781-894-0800
200 PROSPECT ST.                  SE DECISION MADE: 02-DEC-99
WALTHAM, MA 02254-9141            510(k) STATEMENT

DEVICE: UROVIEW 2800
OEC MEDICAL SYSTEMS, INC.         510(k) NO: K993687(ABBREVIATED)
ATTN: TED L PARROT                PHONE NO : 801-536-4694
384 WRIGHT BROTHERS DR.           SE DECISION MADE: 21-DEC-99
SALT LAKE CITY, UT 84116          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHEST DRAINAGE TUBING
OLSON MEDICAL SALES, INC.         510(k) NO: K993062(TRADITIONAL)
ATTN: GARRY A COURTNEY            PHONE NO : 410-392-7231
2101 COTTONTAIL LANE              SE DECISION MADE: 10-DEC-99
SOMERSET, NJ 08873                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNICORDER BIOSCAN SYSTEM
OMNICORDER TECHNOLOGIES, INC.     510(k) NO: K990416(TRADITIONAL)
ATTN: MARK  FAUCI                 PHONE NO : 516-444-6499
25 EAST LOOP RD.                  SE DECISION MADE: 23-DEC-99
STONY BROOK, NY 11790-3550        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNISONIC ENDOSCOPIC DEFLECTOR
OMNISONICS MEDICAL TECHNOLOGIES   510(k) NO: K993445(TRADITIONAL)
ATTN: DEBBIE  IAMPIETRO           PHONE NO : 508-435-9893
7 TIFFANY TRAIL                   SE DECISION MADE: 06-DEC-99
HOPKONTON, MA 01748               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: OMNISONICS ULTRASONIC PROBES
OMNISONICS MEDICAL TECHNOLOGIES   510(k) NO: K993628(TRADITIONAL)
ATTN: DEBBIE  IAMPIETRO           PHONE NO : 508-435-9893
7 TIFFANY TRAIL                   SE DECISION MADE: 15-DEC-99
HOPKONTON, MA 01748               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
ORATEC INTERVENTIONS, INC.        510(k) NO: K993854(SPECIAL)
ATTN: SHIELA  RAMERMAN            PHONE NO : 650-369-9904
3700 HAVEN CT.                    SE DECISION MADE: 06-DEC-99
MENLO PARK, CA 94025              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
ORATEC INTERVENTIONS, INC.        510(k) NO: K993967(SPECIAL)
ATTN: JENNIFER  BRENNAN           PHONE NO : 650-369-9904
3700 HAVEN CT.                    SE DECISION MADE: 17-DEC-99
MENLO PARK, CA 94025              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACT/ALERT SN
ORGANON TEKNIKA CORP.             510(k) NO: K993421(TRADITIONAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 14-DEC-99
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACT/ALERT SA
ORGANON TEKNIKA CORP.             510(k) NO: K993423(TRADITIONAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 15-DEC-99
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BACT/ALERT MP PROCESS BOTTLE
ORGANON TEKNIKA CORP.             510(k) NO: K993576(TRADITIONAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 14-DEC-99
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IM
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K994145(SPECIAL)
ATTN: MARLENE A SHULMAN           PHONE NO : 716-453-4110
100 INDIGO CREEK DRIVE            SE DECISION MADE: 22-DEC-99
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OMNIAXIAL CONNECTOR
ORTHOTEC, L.L.C.                  510(k) NO: K993926(SPECIAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 17-DEC-99
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389

DEVICE: HEMOCHEK-A1C SAMPLE COLLECTION KIT
OSBORN GROUP, INC.                510(k) NO: K990899(TRADITIONAL)
ATTN: GILBERT P BOURK III         PHONE NO : 913-390-7146
14901 WEST 117TH STREET           SE DECISION MADE: 21-DEC-99
OLATHE, KS 66062                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: PALL SUPOR AEF FILTER
PALL CORP.                        510(k) NO: K993379(TRADITIONAL)
ATTN: LEONARD S BERMAN            PHONE NO : 516-484-5400
2200 NOTHERN BLVD.                SE DECISION MADE: 16-DEC-99
EAST HILLS, NY 11548              510(k) STATEMENT

DEVICE: HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINAT
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K993621(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH          SE DECISION MADE: 29-DEC-99
SEREMBAN, NAGERI SEMBILAN         510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300

DEVICE: PARAGON LENS CARRIER
PARAGON VISION SCIENCES           510(k) NO: K993486(TRADITIONAL)
ATTN: WILLIAM E MEYERS            PHONE NO : 480-507-7606
947 EAST IMPALA AVE.              SE DECISION MADE: 22-DEC-99
MESA, AZ 85204                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARAGON LENS VIAL
PARAGON VISION SCIENCES           510(k) NO: K993487(TRADITIONAL)
ATTN: WILLIAM E MEYERS            PHONE NO : 480-507-7606
947 EAST IMPALA AVE.              SE DECISION MADE: 22-DEC-99
MESA, AZ 85204                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCAL MEDICAL AB MENIETT 20
PASCAL MEDICAL AB                 510(k) NO: K991562(TRADITIONAL)
ATTN: JEFFREY R SIDEMAN           PHONE NO : 612-835-4018
7307 GLOUCHESTER DRIVE            SE DECISION MADE: 28-DEC-99
MINNEAPOLIS, MN 55435             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
PHAMATECH                         510(k) NO: K994093(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 16-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9073
PHAMATECH                         510(k) NO: K994219(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9078
PHAMATECH                         510(k) NO: K994220(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 619-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9068
PHAMATECH                         510(k) NO: K994233(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: AT HOME DRUG TEST, MODEL 9083
PHAMATECH                         510(k) NO: K994234(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9133
PHAMATECH                         510(k) NO: K994236(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AT HOME DRUG TEST, MODEL 9063
PHAMATECH                         510(k) NO: K994237(SPECIAL)
ATTN: CARL A MONGIOVI             PHONE NO : 858-635-5840
9265 ACTIVITY RD., #112-113       SE DECISION MADE: 30-DEC-99
SAN DIEGO, CA 92126               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54,
PHARMACIA & UPJOHN CO.            510(k) NO: K993388(TRADITIONAL)
ATTN: KAREN E MATIS               PHONE NO : 614-794-3324
5094 ST. ANDREWS DRIVE            SE DECISION MADE: 01-DEC-99
WESTERVILLLE, OH 43082            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHILIPS EASYVISION WORKSTATION
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K990329(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203-926-7031
710 BRIDGEPORT AVENUE             SE DECISION MADE: 07-DEC-99
P.O. BOX 860                      510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-0917

DEVICE: PHILIPS INTURIS DICOM RECORDER
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K993227(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203-926-7031
710 BRIDGEPORT AVE.               SE DECISION MADE: 21-DEC-99
SHELTON, CT 06484                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
POINTE SCIENTIFIC, INC.           510(k) NO: K993590(TRADITIONAL)
ATTN: WILLIAM F WALTERS JR.       PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR.          SE DECISION MADE: 21-DEC-99
LINCOLN PARK, MI 48146            510(k) STATEMENT

DEVICE: MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
POLYMER TECHNOLOGY SYSTEMS, INC.  510(k) NO: K983860(TRADITIONAL)
ATTN: MARGO  ENRIGHT              PHONE NO : 317-870-5610
7736 ZIONSVILLE ROAD              SE DECISION MADE: 27-DEC-99
INDIANAPOLIS, IN 46268            510(k) STATEMENT

DEVICE: PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
PRIMUS CORP.                      510(k) NO: K994045(SPECIAL)
ATTN: JIM  NOFFSINGER             PHONE NO : 816-523-7491
7235 CENTRAL                      SE DECISION MADE: 21-DEC-99
KANSAS CITY, MO 64114             510(k) STATEMENT
 
DEVICE: PRIMUS STEAM STERILIZERS
PRIMUS STERILIZER CO., INC.       510(k) NO: K991575(ABBREVIATED)
ATTN: JEFF  REED                  PHONE NO : 402-344-4200
117 SOUTH 25TH ST.                SE DECISION MADE: 03-DEC-99
OMAHA, NE 68131                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANUAL BONE MARROW BIOPSY DEVICE
PROMEX, INC.                      510(k) NO: K993435(TRADITIONAL)
ATTN: JOSEPH L MARK               PHONE NO : 317-736-0128
3062 HUDSON ST.                   SE DECISION MADE: 06-DEC-99
FRANKLIN, IN 46131                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PULPDENT UNO-DUO
PULPDENT CORP.                    510(k) NO: K993683(TRADITIONAL)
ATTN: KENNETH J BERK              PHONE NO : 617-926-6666
80 OAKLAND ST.                    SE DECISION MADE: 13-DEC-99
WATERTOWN, MA 02471-0780          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT
QUALITY LATEX CORP. SDN BHD       510(k) NO: K993271(TRADITIONAL)
ATTN: SHARENE  WAN                PHONE NO : 605 527 7228
18-20, JALAN KILANG 2,            SE DECISION MADE: 02-DEC-99
JELANPANG LIGHT INDUST. ESTATE    510(k) STATEMENT
IPOH, PERAK, MALAYSIA 30100

DEVICE: QUANTECH TOTAL B-HCG ASSAY
QUANTECH LTD.                     510(k) NO: K990258(TRADITIONAL)
ATTN: ROBIN  HELLEN               PHONE NO : 818-709-5646
9418 LASAINE AVE                  SE DECISION MADE: 21-DEC-99
NORTHRIDGE, CA 91325              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DELIGHT II HAIR REMOVAL SYSTEM (THE "DELIGHT SYSTEM")
RADIANCY, LTD.                    510(k) NO: K992482(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 13TH STREET NW                SE DECISION MADE: 27-DEC-99
WASHINGTON, DC 20004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONFORMAX MMLC VR1
RADIONICS, INC.                   510(k) NO: K993594(SPECIAL)
ATTN: NANCY  MACDONALD            PHONE NO : 781-272-1233
22 TERRY AVE.                     SE DECISION MADE: 15-DEC-99
BURLINGTON, MA 01803              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RTD ARM ASSISTIVE ROBOTIC DEVICE
REHABILITATION TECHNOLOGIES DIVISI510(k) NO: K993443(TRADITIONAL)
ATTN: RICHARD M MAHONEY           PHONE NO : 973-575-0650
1275 BLOOMFIELD AVENUE            SE DECISION MADE: 17-DEC-99
FAIRFIELD, NJ 07004               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 3
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K993103(TRADITIONAL)
ATTN: ROBERT L CASARA             PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 10-DEC-99
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: RITA MODEL 1500 ELECTROSURGICAL GENERATOR, POWER CORD,FOOTSWITCH
RITA MEDICAL SYSTEMS              510(k) NO: K993944(TRADITIONAL)
ATTN: ERIN  DIGNAN-MAZZONE        PHONE NO : 650-390-8500
967 NORTH SHORELINE BLVD.         SE DECISION MADE: 02-DEC-99
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
ROCAP DIV. OF SABRATEK CORP.      510(k) NO: K990308(TRADITIONAL)
ATTN: AVIA  TONEY                 PHONE NO : 407-855-5104
1629 PRIME CT., SUITE 300         SE DECISION MADE: 10-DEC-99
ORLANDO, FL 32809                 510(k) STATEMENT

DEVICE: HEPARIN IV FLUSH SYRINGE, 10 U/ML  \
ROCAP DIV. OF SABRATEK CORP.      510(k) NO: K990390(TRADITIONAL)
ATTN: AVIA  TONEY                 PHONE NO : 407-855-5104
1629 PRIME CT., SUITE 300         SE DECISION MADE: 10-DEC-99
ORLANDO, FL 32809                 510(k) STATEMENT

DEVICE: ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
ROCHE DIAGNOSTICS CORP.           510(k) NO: K993048(TRADITIONAL)
ATTN: LUANN  OCHS                 PHONE NO : 317-576-7399
9115 HAGUE RD.                    SE DECISION MADE: 20-DEC-99
INDIANAPOLIS, IN 46250-0457       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCU-CHEK SIMPLICITY SYSTEM
ROCHE DIAGNOSTICS CORP.           510(k) NO: K993829(SPECIAL)
ATTN: MIKE  FLIS                  PHONE NO : 800-428-5074
9115 HAGUE ROAD                   SE DECISION MADE: 09-DEC-99
P.O. BOX 50457                    510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457

DEVICE: ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
ROCHE MOLECULAR SYSTEMS, INC.     510(k) NO: K974503(TRADITIONAL)
ATTN: ALEX  WESOLOWSKI            PHONE NO :
1080 U.S. HIGHWAY 202             SE DECISION MADE: 01-DEC-99
SOMERVILLE, NJ 08876-3711         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
ROSSMAX INTL. LTD.                510(k) NO: K993432(SPECIAL)
ATTN: MICHAEL  YEH                PHONE NO : 011 886 27835584
2F. NO. 8, ALLEY 20 LANE 106      SE DECISION MADE: 20-DEC-99
SECTION 3, NAN KANG ROAD          510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)

DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
ROSSMAX INTL. LTD.                510(k) NO: K993542(SPECIAL)
ATTN: MICHAEL  YEH                PHONE NO : 011 886 278384
2F. NO. 8, ALLEY 20 LANE 106      SE DECISION MADE: 29-DEC-99
SECTION 3, NAN KANG ROAD          510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)

DEVICE: RUSCH BRILLANT SILICONE FOLEY
RUSCH INTL.                       510(k) NO: K993063(TRADITIONAL)
ATTN: JULIE A BEAUMONT            PHONE NO : 603-532-7706
TALL PINES PARK                   SE DECISION MADE: 09-DEC-99
JAFFREY, NH 03452                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
SC HENNIG ENTERPRISES EUROPE SRL  510(k) NO: K993651(TRADITIONAL)
ATTN: GEORGE  O'NEIL              PHONE NO :
25 SHANN STREET                   SE DECISION MADE: 23-DEC-99
FLOREAT PARK                      510(k) STATEMENT
WESTERN AUSTRALIA, AUSTRALIA 6014

DEVICE: QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
SERACARE TECHNOLOGY               510(k) NO: K992939(TRADITIONAL)
ATTN: RUSTY  SEWELL               PHONE NO : 512-445-5100
2170 WOODWARD ST.                 SE DECISION MADE: 09-DEC-99
AUSTIN, TX 78744-1832             510(k) STATEMENT

DEVICE: QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
SERACARE TECHNOLOGY               510(k) NO: K993631(TRADITIONAL)
ATTN: RUSTY  SEWELL               PHONE NO : 512-445-5100
2170 WOODWARD ST.                 SE DECISION MADE: 09-DEC-99
AUSTIN, TX 78744-1832             510(k) STATEMENT

DEVICE: PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
SHANGHAI CHAMPION PLASTIC PRODUCTS510(k) NO: K994036(TRADITIONAL)
ATTN: JANNA P TUCKER              PHONE NO : 775-342-2612
198 AVE. DE LA D' EMERALD         SE DECISION MADE: 20-DEC-99
SPARKS, NV 89434-9550             510(k) STATEMENT

DEVICE: KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAM
SIEMENS CORP.                     510(k) NO: K993947(TRADITIONAL)
ATTN: ALICIA  JUERGENSEN          PHONE NO : 732-321-3243
186 WOOD AVE., SOUTH              SE DECISION MADE: 21-DEC-99
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K993731(TRADITIONAL)
ATTN: KATHLEEN  RUTHERFORD        PHONE NO : 732-321-4625
186 WOOD AVENUE SOUTH             SE DECISION MADE: 23-DEC-99
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
SIGMA DIAGNOSTICS, INC.           510(k) NO: K992711(TRADITIONAL)
ATTN: WILLIAM R GILBERT           PHONE NO : 314-286-6693
545 SOUTH EWING AVE.              SE DECISION MADE: 06-DEC-99
ST. LOUIS, MO 63103               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
SIGMA DIAGNOSTICS, INC.           510(k) NO: K992712(TRADITIONAL)
ATTN: WILLIAM R GILBERT           PHONE NO : 314-286-7835
545 SOUTH EWING AVE.              SE DECISION MADE: 06-DEC-99
ST. LOUIS, MO 63103               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND A
SMITH & NEPHEW, INC.              510(k) NO: K993106(ABBREVIATED)
ATTN: JANET JOJNSON  GREEN        PHONE NO : 901-399-5153
1450 E. BROOKS ROAD               SE DECISION MADE: 09-DEC-99
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP
SMITH & NEPHEW, INC.              510(k) NO: K993289(ABBREVIATED)
ATTN: JANET  JOHNSON GREEN        PHONE NO : 901-399-5153
1450 E. BROOKS ROAD               SE DECISION MADE: 20-DEC-99
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
SODEM SYSTEMS                     510(k) NO: K994175(SPECIAL)
ATTN: DANIEL  BACCINO             PHONE NO : 41 227 949696
110 CH. DU PONT DU CENTENAIRE     SE DECISION MADE: 21-DEC-99
GENEVA, SWITZERLAND CH-1228       510(k) STATEMENT

DEVICE: SODEM PERFORATOR DRIVE
SODEMSYSTEMS                      510(k) NO: K993851(TRADITIONAL)
ATTN: DANIEL  BACCINO             PHONE NO : 412 279 49696
110, CH. DU PONT-DU-CENTENAIRE    SE DECISION MADE: 27-DEC-99
GENEVA, SWITZERLAND, SWITZERLAND C510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELITE CUSTOM
SOMA BLUE, INC.                   510(k) NO: K993142(TRADITIONAL)
ATTN: JOHN M MITCHELL             PHONE NO : 706-821-3600
P.O. BOX 1447                     SE DECISION MADE: 27-DEC-99
1025 BROAD STREET                 510(k) STATEMENT
AUGUSTA, GA 30903

DEVICE: VITALITY SYSTEM
SOMA BLUE, INC.                   510(k) NO: K993143(TRADITIONAL)
ATTN: JOHN M MITCHELL             PHONE NO : 706-821-3600
P.O. BOX 1447                     SE DECISION MADE: 27-DEC-99
1025 BROAD STREET                 510(k) STATEMENT
AUGUSTA, GA 30903

DEVICE: SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM
SONOSITE,INC.                     510(k) NO: K994096(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN           PHONE NO : 425-951-1297
19807 NORTH CREEK PKWY., #200     SE DECISION MADE: 20-DEC-99
BOTHELL, WA 98011-8214            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: THE SOUNDVASER DISSECTION SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC   510(k) NO: K993868(TRADITIONAL)
ATTN: WILLIAM W CIMINO            PHONE NO : 303-926-8608
1300 PLAZA COURT NORTH # 203      SE DECISION MADE: 21-DEC-99
LAFAYETTE, CO 80026               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
SPACELABS MEDICAL, INC.           510(k) NO: K981655(TRADITIONAL)
ATTN: NANCY  GERTLAR              PHONE NO : 425-882-3700
P.O. BOX 97013                    SE DECISION MADE: 03-DEC-99
REDMOND, WA 98073-9713            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
SPINEOLOGY GROUP, LLC             510(k) NO: K990959(ABBREVIATED)
ATTN: PAMELA  SNYDER              PHONE NO : 651-351-1011
1815 NORTHWESTERN AVE.            SE DECISION MADE: 27-DEC-99
STILLWATER, MN 55082              510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LA
SRI JOHANI SDN. BHD.              510(k) NO: K993454(TRADITIONAL)
ATTN: LIM LEE  AIK                PHONE NO : 603 961 1211
LOT PT 7178, BALAKONG N/V,        SE DECISION MADE: 03-DEC-99
SERI KEMBANGAN                    510(k) STATEMENT
SELANGOR, MALAYSIA 43300

DEVICE: POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MI
SRI JOHANI SDN. BHD.              510(k) NO: K993457(TRADITIONAL)
ATTN: LIM LEE  AIK                PHONE NO : 603 961 1211
LOT PT 7178, BALAKONG N/V,        SE DECISION MADE: 02-DEC-99
SERI KEMBANGAN                    510(k) STATEMENT
SELANGOR, MALAYSIA 43300

DEVICE: EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
STELLAR BIO SYSTEMS, INC.         510(k) NO: K992587(TRADITIONAL)
ATTN: JOHN  BREWER                PHONE NO : 410-381-8550
9075 GUILFORD RD.                 SE DECISION MADE: 22-DEC-99
COLUMBIA, MD 21046                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CPAP/PRO CPAP INTERFACE
STEVENSON INDUSTRIES, INC.        510(k) NO: K992384(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE                  SE DECISION MADE: 01-DEC-99
SUITE C-100                       510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523

DEVICE: HANG UPS INVERTALIGN
STL INTL., INC.                   510(k) NO: K991835(TRADITIONAL)
ATTN: ROGER C TEETER              PHONE NO : 253-840-5252
10004 162ND ST. CT. EAST          SE DECISION MADE: 20-DEC-99
PUYULLUP, WA 98375                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERFACE MODULE IDDD
STOCKERT INSTRUMENTE              510(k) NO: K992635(SPECIAL)
ATTN: MARY  MCNAMARA-CULLINANE    PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 20-DEC-99
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
STRYKER CORP.                     510(k) NO: K991706(TRADITIONAL)
ATTN: NICOLE  PETTY               PHONE NO : 800-253-3210
4100 EAST MILHAM AVENUE           SE DECISION MADE: 07-DEC-99
KALAMAZOO, MI 49001-6197          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER,
STRYKER INSTRUMENTS               510(k) NO: K994053(SPECIAL)
ATTN: SUSANNE  VELAQUEZ           PHONE NO : 616-323-7700
4100 EAST MILHAM AVE.             SE DECISION MADE: 20-DEC-99
KALAMAZOO, MI 49001               510(k) STATEMENT

DEVICE: SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
SULZER CARBOMEDICS, INC.          510(k) NO: K993288(TRADITIONAL)
ATTN: EDWARD E NEWTON             PHONE NO : 512-435-3407
1300 EAST ANDERSON LN.            SE DECISION MADE: 29-DEC-99
AUSTIN, TX 78752                  510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: APR METASUL ACETABULAR INSERT
SULZER MEDICA                     510(k) NO: K993569(SPECIAL)
ATTN: MITCHELL A DHORITY          PHONE NO : 512-432-9900
9900 SPECTRUM DRIVE               SE DECISION MADE: 01-DEC-99
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MS-30 FEMORAL STEM
SULZER ORTHOPEDICS, INC.          510(k) NO: K993043(TRADITIONAL)
ATTN: MITCHELL A DHORITY          PHONE NO : 512-432-9900
9900 SPECTRUM DR.                 SE DECISION MADE: 02-DEC-99
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
SULZERMEDICA                      510(k) NO: K990503(TRADITIONAL)
ATTN: EDWARD E NEWTON             PHONE NO : 512-435-3407
1300 EAST ANDERSON LANE           SE DECISION MADE: 09-DEC-99
AUSTIN, TX 78752                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERM
SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K993485(TRADITIONAL)
ATTN: MING  SUN                   PHONE NO : 856-401-1080
604 VPR CENTER                    SE DECISION MADE: 27-DEC-99
1001 LOWER LANDING RD.            510(k) SUMMARY AVAILABLE FROM FDA
BLACKWOOD, NJ 08012

DEVICE: SURE-WAY REUSABLE SHARPS CONTAINER
SURE-WAY SYSTEMS, INC.            510(k) NO: K992626(TRADITIONAL)
ATTN: GARY  CHILCOTT              PHONE NO : 310-522-0150
310 HARRY BRIDGES BLVD.           SE DECISION MADE: 16-DEC-99
WILMINGTON, CA 90744              510(k) STATEMENT

DEVICE: STEALTHSTATION TREATMENT GUIDANCE PLATFORM
SURGICAL NAVIGATION TECHNOLOGIES, 510(k) NO: K992927(TRADITIONAL)
ATTN: ANGELIQUE  DESTRUEL         PHONE NO : 303-439-9709
530 COMPTON ST.                   SE DECISION MADE: 29-DEC-99
BROOMFIELD, CO 80020              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
SURVIVALINK CORP.                 510(k) NO: K993072(TRADITIONAL)
ATTN: SEW-WAH  TAY                PHONE NO : 612-939-2942
5420 FELTL RD.                    SE DECISION MADE: 10-DEC-99
MINNEAPOLIS, MN 55343             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PHARMASEED, MODEL BT-125-1
SYNCOR PHARMACEUTICALS, INC.      510(k) NO: K992008(TRADITIONAL)
ATTN: GARY  GILMORE               PHONE NO : 303-279-1914
1313 WASHINGTON AVENUE            SE DECISION MADE: 23-DEC-99
GOLDEN, CO 80401                  510(k) STATEMENT

DEVICE: SYNTHES LIGHT GUIDE
SYNTHES (USA)                     510(k) NO: K993314(ABBREVIATED)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
1303 GOSHEN PKWY.                 SE DECISION MADE: 06-DEC-99
WEST CHESTER, PA 19380            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES (USA)                     510(k) NO: K994187(SPECIAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
P.O. BOX 0548                     SE DECISION MADE: 21-DEC-99
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVE
SYVA CO.                          510(k) NO: K993755(ABBREVIATED)
ATTN: PAUL L ROGERS               PHONE NO : 408-239-2309
3403 YERBA BUENA RD.              SE DECISION MADE: 21-DEC-99
P.O. BOX 49013                    510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95161-9013

DEVICE: E. HISTOLYTICA II
TECHLAB, INC.                     510(k) NO: K994101(SPECIAL)
ATTN: DAVID M LYERLY              PHONE NO : 800-832-4522
1861 PRATT DR., STE. 1030         SE DECISION MADE: 21-DEC-99
BLACKSBURG, VA 24060-6364         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORC
TELEMED SYSTEMS, INC.             510(k) NO: K992390(TRADITIONAL)
ATTN: JOHN A CHAVES               PHONE NO : 508-481-6718
19 BRIGHAM ST., UNIT 1            SE DECISION MADE: 22-DEC-99
MARLBOROUGH, MA 01752             510(k) STATEMENT

DEVICE: 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENC
TELEMED SYSTEMS, INC.             510(k) NO: K992402(TRADITIONAL)
ATTN: JOHN A CHAVES               PHONE NO : 508-481-6718
19 BRIGHAM ST., UNIT 1            SE DECISION MADE: 22-DEC-99
MARLBOROUGH, MA 01752             510(k) STATEMENT

DEVICE: DRUG STOP
TEXAS IMMUNOLOGY, INC.            510(k) NO: K991465(TRADITIONAL)
ATTN: CHARLES W GILL              PHONE NO : 903-566-6696
12524 FM 3226                     SE DECISION MADE: 10-DEC-99
TYLER, TX 75707                   510(k) STATEMENT

DEVICE: POWDER FREE LATEX STERILE SURGICAL GLOVES
TG MEDICAL SDN BHD                510(k) NO: K993562(TRADITIONAL)
ATTN: T.S.  PUON                  PHONE NO : 603 392 7880
LOT 5091, JALAN TERATAI, BT 5,    SE DECISION MADE: 29-DEC-99
OFF JLN MERU                      510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 41050

DEVICE: C3 MININEPH ANTISERUM
THE BINDING SITE, LTD.            510(k) NO: K981783(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404
 
DEVICE: IGM MININEPH ANTISERUM
THE BINDING SITE, LTD.            510(k) NO: K981784(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 21-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: C4 MININEPH ANTISERUM
THE BINDING SITE, LTD.            510(k) NO: K981785(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATI
THE BINDING SITE, LTD.            510(k) NO: K981915(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
THE BINDING SITE, LTD.            510(k) NO: K982100(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 20-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
THE BINDING SITE, LTD.            510(k) NO: K993612(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 21-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: BINDAZYME ANTI-DSDNA EIA KIT
THE BINDING SITE, LTD.            510(k) NO: K993727(TRADITIONAL)
ATTN: JAY H GELLER                PHONE NO : 310-449-1399
EAST TOWER, SUITE 600             SE DECISION MADE: 21-DEC-99
2425 WEST OLYMPIC BOULEVARD       510(k) STATEMENT
SANTA MONICA, CA 90404

DEVICE: MPM REGENECARE WOUND GEL
THE DIVERSIFIED COMPANIES         510(k) NO: K992074(TRADITIONAL)
ATTN: RICHARD A HAMER             PHONE NO : 817-294-3644
6401 MEADOWS WEST DRIVE           SE DECISION MADE: 23-DEC-99
FORT WORTH, TX 76132              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODUS SAGITTAL SPLIT PLATE
THE STRAUMANN CO.                 510(k) NO: K993862(TRADITIONAL)
ATTN: LINDA  JALBERT              PHONE NO : 800-448-8168
RESERVOIR PL. 1601 TRAPELO RD.    SE DECISION MADE: 29-DEC-99
WALTHAM, MA 02154                 510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING
THERMOLASE CORP.                  510(k) NO: K993209(TRADITIONAL)
ATTN: GERALD  FELDMAN, MPH, MBA   PHONE NO : 732-329-1787
6 WESTMINSTER PLACE               SE DECISION MADE: 23-DEC-99
MONMOUTH JCT., NJ 08852           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GREEN POWDERED LATEX EXAMINATION GLOVES
TOP GLOVE SDN. BHD.               510(k) NO: K993452(TRADITIONAL)
ATTN: T.S.  PUON                  PHONE NO : 603 392 1992
LOT 4968 JALAN TERATAI, BATU 6    SE DECISION MADE: 20-DEC-99
OFFJALAN MERU, 41050 KLANG        510(k) STATEMENT
SELANGOR, D.E., MALAYSIA

DEVICE: PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
TOP GLOVE SDN. BHD.               510(k) NO: K993605(TRADITIONAL)
ATTN: WEE-CHAI  LIM               PHONE NO : 603 392 12918410
LOT 4968 JALAN TERATAI, BATU 6    SE DECISION MADE: 20-DEC-99
OFFJALAN MERU, 41050 KLANG        510(k) STATEMENT
SELANGOR, D.E., MALAYSIA

DEVICE: SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE
TOP GLOVE SDN. BHD.               510(k) NO: K993680(TRADITIONAL)
ATTN: WEE-CHAI  LIM               PHONE NO : 603 392 1992
41050 KLANG,SELANGOR              SE DECISION MADE: 13-DEC-99
DARUL EHSAN, MALAYSIA             510(k) STATEMENT

DEVICE: AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K992992(TRADITIONAL)
ATTN: DIANA  THORSON              PHONE NO : 714-730-5000
2441 MICHELLE DRIVE               SE DECISION MADE: 03-DEC-99
P O BOX 2068                      510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068

DEVICE: UNI-GOLD H. PYLORI
TRINITY BIOTECH, PLC              510(k) NO: K991697(TRADITIONAL)
ATTN: ERIKA B AMMIRATI            PHONE NO : 650-949-2768
575 SHIRLYNN COURT                SE DECISION MADE: 21-DEC-99
LOS ALTOS, CA 94022               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CLEARPLAN EASY II HOME PREGNANCY TEST
UNIPATH LTD.                      510(k) NO: K993333(TRADITIONAL)
ATTN: LOUISE  ROBERTS             PHONE NO : 441 234 835564
PRIORY BUSINESS PARK              SE DECISION MADE: 16-DEC-99
BEDFORD, UNITED KINGDOM MK44 3UP  510(k) STATEMENT

DEVICE: CLEARVIEW EASY HCG PREGNANCY TEST
UNIPATH LTD.                      510(k) NO: K993703(TRADITIONAL)
ATTN: LOUISE  ROBERTS             PHONE NO : 441 234 835564
PRIORY BUSINESS PARK              SE DECISION MADE: 02-DEC-99
BEDFORD, UNITED KINGDOM MK 44 3UP 510(k) STATEMENT

DEVICE: QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B,
UNITED PACIFIC CO., LTD.          510(k) NO: K993123(TRADITIONAL)
ATTN: DANIEL YE  HUA              PHONE NO : 626-458-8518
219 SOUTH RAYMOND AVE.            SE DECISION MADE: 17-DEC-99
ALHAMBRA, CA 91801                510(k) STATEMENT
 
DEVICE: BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K984168(TRADITIONAL)
ATTN: DEAN  SECREST               PHONE NO : 440-639-4494
5976 HEISELY ROAD                 SE DECISION MADE: 07-DEC-99
MENTOR, OH 44060                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TONGUE STABILIZER DEVICE
UNIVERSITY OF OTAGO               510(k) NO: K993381(TRADITIONAL)
ATTN: CHRISTINA M LAJOIE          PHONE NO : 716-695-6251
199 FIRE TOWER DRIVE              SE DECISION MADE: 21-DEC-99
P.O. BOX 5111                     510(k) STATEMENT
TONAWANDA, NY 14151-5111

DEVICE: LEMAITRE EMBOLECTOMY CATHETER
VASCUTECH, INC.                   510(k) NO: K992368(TRADITIONAL)
ATTN: TRENT G KAMKE               PHONE NO : 781-221-2266
164 MIDDLESEX TURNPIKE            SE DECISION MADE: 09-DEC-99
BURLINGTON, MA 01803              510(k) STATEMENT

DEVICE: PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/961
VIDAR SYSTEMS CORP.               510(k) NO: K993597(TRADITIONAL)
ATTN: MARY "PENNIE"  DRINKARD     PHONE NO : 703-471-7070
460 SPRING PARK PL.               SE DECISION MADE: 15-DEC-99
HERNDON, VA 20170                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: WAKO L-TYPE GOT TEST
WAKO CHEMICALS, USA, INC.         510(k) NO: K993468(TRADITIONAL)
ATTN: TONYA  MALLORY              PHONE NO : 800-992-9256
1600 BELLWOOD RD.                 SE DECISION MADE: 16-DEC-99
RICHMOND, VA 23237                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PATIENT LATEX EXAMINATION "POWDER-FREE" POLYMER COATED GLOVES
WEAR SAFE MALAYSIA SDN. BHD.      510(k) NO: K992676(TRADITIONAL)
ATTN: CLAUDE  COTTET              PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU,    SE DECISION MADE: 16-DEC-99
NORTH KLANG STRAITS IND. AREA     510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000

DEVICE: PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
WEAR SAFE MALAYSIA SDN. BHD.      510(k) NO: K992681(TRADITIONAL)
ATTN: CLAUDE  COTTET              PHONE NO : 03 376 3525
LOT 1, LEBOH HISHAMUDDIN SATU,    SE DECISION MADE: 16-DEC-99
NORTH KLANG STRAITS IND. AREA     510(k) STATEMENT
PORT KLANG, SELANGOR, D.E., MALAYSIA 42000

DEVICE: HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER
WECK CLOSURE SYSTEMS              510(k) NO: K993157(TRADITIONAL)
ATTN: BRIAN  YOUNG                PHONE NO : 919-361-4041
ONE WECK DR.                      SE DECISION MADE: 17-DEC-99
RESEARCH TRIANGLE PARK, NC 27709  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT
WESLEY JESSEN CORP.               510(k) NO: K993935(TRADITIONAL)
ATTN: JOSEPH F FOOS               PHONE NO : 847-294-3306
333 EAST HOWARD AVE.              SE DECISION MADE: 21-DEC-99
DES PLAINES, IL 60018             510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
WINCHESTER LABORATORIES LLC       510(k) NO: K993969(TRADITIONAL)
ATTN: HOWARD  ROSE                PHONE NO : 630-406-8680
325 NORTH WATER STREET            SE DECISION MADE: 30-DEC-99
BATAVIA, IL 60510                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUCPREP BREAST ASPIRATOR, MODEL PMPO2
WINDY HILL TECHNOLOGY, INC.       510(k) NO: K993342(TRADITIONAL)
ATTN: ANGELA B SOITO              PHONE NO : 650-566-2330
1010 HAMILTON COURT               SE DECISION MADE: 23-DEC-99
MENLO COURT, CA 94025             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
WOODSIDE BIOMEDICAL, INC.         510(k) NO: K983907(TRADITIONAL)
ATTN: CAROL L PATTERSON           PHONE NO :
18140 SMOKESIGNAL DRIVE           SE DECISION MADE: 09-DEC-99
SAN DIEGO, CA 92127               510(k) STATEMENT

DEVICE: SADDLE SHAPED PATELLA
WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K993371(TRADITIONAL)
ATTN: LYNNE  WITKOWSKI            PHONE NO : 901-867-4620
5677 AIRLINE RD.                  SE DECISION MADE: 20-DEC-99
ARLINGTON, TN 38002               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMAGRIP POWDER-FREE LATEX SURGICAL GLOVE, STERILE (PROTEIN CON
WRP SPECIALTY PRODUCTS SDN. BHD.  510(k) NO: K993214(TRADITIONAL)
ATTN: OOI SOO  KANG               PHONE NO : 603 846 2055
LOT11, JL.2,KAWASAN PERUSAHAAN    SE DECISION MADE: 02-DEC-99
BANDAR BARU SLAK TINGGI           510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900

DEVICE: DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE
WRP SPECIALTY PRODUCTS SDN. BHD.  510(k) NO: K993215(TRADITIONAL)
ATTN: OOI SOO  KANG               PHONE NO : 603 846 2055
LOT11, JL.2,KAWASAN PERUSAHAAN    SE DECISION MADE: 02-DEC-99
BANDAR BARU SLAK TINGGI           510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900

DEVICE: PENSIL TRAUMA, MODEL WWS6100
WUESTEC MEDICAL, INC.             510(k) NO: K993962(TRADITIONAL)
ATTN: BRENDA S. D.  DAVIS         PHONE NO : 334-408-0200
5600 COMMERCE BLVD., EAST         SE DECISION MADE: 21-DEC-99
MOBILE, AL 36619-0037             510(k) STATEMENT

DEVICE: XOMED ENT RF SYSTEM
XOMED, INC.                       510(k) NO: K993112(TRADITIONAL)
ATTN: MARTIN D SARGENT            PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 09-DEC-99
JACKSONVILLE, FL 32216            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
XOMED, INC.                       510(k) NO: K993655(TRADITIONAL)
ATTN: MARTIN D SARGENT            PHONE NO : 904-279-7586
6743 SOUTHPOINT DR. NORTH         SE DECISION MADE: 21-DEC-99
JACKSONVILLE, FL 32216            510(k) SUMMARY AVAILABLE FROM FDA
 
DEVICE: THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
Y-CLIP ASSOCIATES                 510(k) NO: K993424(TRADITIONAL)
ATTN: GEORGE  YU                  PHONE NO :
116 DEFENSE HIGHWAY               SE DECISION MADE: 23-DEC-99
ANNAPOLIS, MD 21401               510(k) STATEMENT

 
                                                TOTAL 510(k)s THIS PERIOD   319
                                                TOTAL WITH SUMMARIES        219
                                                TOTAL WITH STATEMENTS       100