August 1999 510(k) Clearances

DEVICE: HOFFMAN IVF-1
(ARMS) HOFFMAN SURGICAL EQUIPMENT,510(k) NO: K991216(TRADITIONAL)
ATTN: FRANK  STRZEMPEK            PHONE NO : 610-834-1450
555 NORTH LANE                    SE DECISION MADE: 05-AUG-99
SUITE 5001                        510(k) STATEMENT
CONSHOHOCKEN, PA 19428

DEVICE: HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
02 MARKETING GROUP INC            510(k) NO: K991569(TRADITIONAL)
ATTN: LESTER  FORD                PHONE NO : 770-663-3090
11285 ELKINS RD                   SE DECISION MADE: 03-AUG-99
SUITE H5                          510(k) STATEMENT
ROSWELL, GA 30076

DEVICE: 3M LVR SYSTEM
3M CO.                            510(k) NO: K991961(TRADITIONAL)
ATTN: LAEL J PICKETT              PHONE NO : 651-733-3594
3M CENTER BUILDING 26O-2B-12      SE DECISION MADE: 09-AUG-99
ST. PAUL, MN 55144-1000           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
A.P. TOTAL CARE, INC.             510(k) NO: K991664(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-335-9277
70 HAWLEY AVE,                    SE DECISION MADE: 19-AUG-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: HDL CHOLESTEROL, PRODUCT NO'S  124-01, CH102-01
A.P. TOTAL CARE, INC.             510(k) NO: K991665(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-335-9277
70 HAWLEY AVE,                    SE DECISION MADE: 10-AUG-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03,
A.P. TOTAL CARE, INC.             510(k) NO: K991866(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-335-9277
70 HAWLEY AVE,                    SE DECISION MADE: 02-AUG-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02
A.P. TOTAL CARE, INC.             510(k) NO: K991867(TRADITIONAL)
ATTN: LUIS P LEON                 PHONE NO : 203-906-7800
70 HAWLEY AVE,                    SE DECISION MADE: 02-AUG-99
PO BOX 6216                       510(k) STATEMENT
BRIDGEPORT, CT

DEVICE: AB2 MED-FLO SOLUTION SET
AB2 MEDICAL PRODUCTS, LLP         510(k) NO: K984569(TRADITIONAL)
ATTN: ARTHUR  CHANDLER,III        PHONE NO : 281-362-0130
52 BUTTONBUSH CT                  SE DECISION MADE: 12-AUG-99
THE WOODLANDS, TX                 510(k) STATEMENT

 
DEVICE: PICCOLO METLYTE 7 REAGENT DISC
ABAXIS INC.                       510(k) NO: K992140(TRADITIONAL)
ATTN: LISA  MCGRATH               PHONE NO : 408-745-6880
1320 CHESAPEAKE TERRACE           SE DECISION MADE: 26-AUG-99
SUNNYVALE, CA 94089               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
ABX DIAGNOSTICS, INC.             510(k) NO: K991839(TRADITIONAL)
ATTN: PAT  AMTOWER                PHONE NO : 949-489-3913
7777 CENTER AVENUE                SE DECISION MADE: 11-AUG-99
SUITE 102                         510(k) SUMMARY AVAILABLE FROM FDA
HUNTINGTON BEACH, CA 92647

DEVICE: ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
ACRYMED, INC.                     510(k) NO: K992032(TRADITIONAL)
ATTN: BRUCE  GIBBINS              PHONE NO : 503-624-9830
12232 S.W. GARDEN PL.             SE DECISION MADE: 19-AUG-99
PORTLAND, OR 97223                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
ACUSON CORP.                      510(k) NO: K991805(TRADITIONAL)
ATTN: WILLIAM  WELCH              PHONE NO : 650-943-7286
1220 CHARLESTON RD.               SE DECISION MADE: 02-AUG-99
MOUNTAIN VIEW, CA 94039-7393      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
ADVANCED TECHNOLOGY LABORATORIES, 510(k) NO: K992470(TRADITIONAL)
ATTN: TERRENCE J SWEENEY          PHONE NO : 425-487-7602
P.O. BOX 3003                     SE DECISION MADE: 23-AUG-99
BOTHELL, WA 98041-3003            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTELLIFLO SPACER
AEROMAX TECHNOLOGIES, INC.        510(k) NO: K984085(TRADITIONAL)
ATTN: ALLAN M WACHTER             PHONE NO : 602-785-8000
12020 S. WARNER/ELLIOT LOOP       SE DECISION MADE: 05-AUG-99
SUITE 124                         510(k) STATEMENT
PHOENIX, AZ 85044

DEVICE: ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
AIRSEP CORP.                      510(k) NO: K992283(TRADITIONAL)
ATTN: GREG  DZIOMBA               PHONE NO : 716-691-0202
290 CREEKSIDE DR.                 SE DECISION MADE: 27-AUG-99
BUFFALO, NY 14228-2070            510(k) STATEMENT

DEVICE: BIOSHIELD EXPRESS STERILIZATION WRAP
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K983719(TRADITIONAL)
ATTN: PATRICIA  SHARPE-GREGG      PHONE NO : 847-578-3636
1500 WAUKEGAN RD.                 SE DECISION MADE: 25-AUG-99
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONVERTORS BREATHABLE SURGICAL GOWNS
ALLEGIANCE HEALTHCARE CORP.       510(k) NO: K992514(SPECIAL)
ATTN: SHARON  ROBBINS             PHONE NO : 847-785-3311
1500 WAUKEGAN RD.                 SE DECISION MADE: 12-AUG-99
MCGAW PARK, IL 60085              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE
ALLIANCE RUBBER PRODUCTS SDN. BHD.510(k) NO: K991981(TRADITIONAL)
ATTN: CHUA HOOI  KOON             PHONE NO : 600 459 32235
PERINDUSTRIAN BUKIT PANCHOR       SE DECISION MADE: 05-AUG-99
14300 NIBONG TEBAL                510(k) STATEMENT
PULAU PINANG, MALAYSIA 52446-U

DEVICE: ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD.                   510(k) NO: K992663(TRADITIONAL)
ATTN: CHRIS  BOHL                 PHONE NO : 203-269-5088
10 FAIRFIELD BLVD.                SE DECISION MADE: 24-AUG-99
WALLINGFORD, CT 06492             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEPTUNE WASTE MANAGEMENT SYSTEM
AMERICAN IMMUNO TECH              510(k) NO: K990037(TRADITIONAL)
ATTN: ESTHER  SALTZ               PHONE NO : 949-830-4235
320 KALMUS DRIVE                  SE DECISION MADE: 24-AUG-99
COSTA MESA, CA 92626              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FETALGARD 3000 FETAL MONITOR
ANALOGIC CORP.                    510(k) NO: K983395(TRADITIONAL)
ATTN: STEVEN  CLARKE              PHONE NO : 978-977-3000
8 CENTENNIAL DR.                  SE DECISION MADE: 12-AUG-99
PEABODY, MA 01960                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: APPLIED BIOTECH SURESTEP HCG/COMBO (II) PREGNANCY TEST
APPLIED BIOTECH, INC.             510(k) NO: K992187(TRADITIONAL)
ATTN: ROGER  KOTTER               PHONE NO : 619-587-6771
10237 FLANDERS CT.                SE DECISION MADE: 04-AUG-99
SAN DIEGO, CA 92121               510(k) STATEMENT

DEVICE: THERMOFLEX SYSTEM
ARGOMED, INC.                     510(k) NO: K991847(TRADITIONAL)
ATTN: RICHARD B KLEIN             PHONE NO : 919-469-2340
3800 GATEWAY CENTER BLVD          SE DECISION MADE: 26-AUG-99
MORRISVILLE, NC 27560             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ARTHREX MENISCAL DART SYSTEM
ARTHREX, INC.                     510(k) NO: K983577(TRADITIONAL)
ATTN: SCOTT M DURLACHER           PHONE NO : 941-643-5553
2885 SOUTH HORSESHOE DR.          SE DECISION MADE: 13-AUG-99
NAPLES, FL 34104                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ADVANTA GRAFT
ATRIUM MEDICAL CORP.              510(k) NO: K992441(SPECIAL)
ATTN: KAREN  HALL                 PHONE NO : 603-880-1433
5 WENTWORTH DR.                   SE DECISION MADE: 20-AUG-99
HUDSON, NH 03051                  510(k) STATEMENT

DEVICE: ADVANTA GRAFT
ATRIUM MEDICAL CORP.              510(k) NO: K992443(SPECIAL)
ATTN: KAREN  HALL                 PHONE NO : 603-880-1433
5 WENTWORTH DR.                   SE DECISION MADE: 20-AUG-99
HUDSON, NH 03051                  510(k) STATEMENT

 
DEVICE: JOBST READY-TO-WEAR ARM SLEEVES
BEIERSDORF-JOBT, INC.             510(k) NO: K991570(TRADITIONAL)
ATTN: ANGELO R PEREIRA            PHONE NO : 704-551-7178
5825 CARNEGIE BLVD.               SE DECISION MADE: 20-AUG-99
CHARLOTTE, NC 28209-4633          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
BELMONT INSTRUMENT CORP.          510(k) NO: K992672(SPECIAL)
ATTN: URAIWAN  LABADINI           PHONE NO : 978-663-0212
780 BOSTON RD.                    SE DECISION MADE: 24-AUG-99
BILLERICA, MA 01821               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MED-RX EXTENSION SETS
BENLAN INC.                       510(k) NO: K990777(TRADITIONAL)
ATTN: BILL  C.K. LIM              PHONE NO : 905 829 5004
2760 BRIGHTON RD.                 SE DECISION MADE: 25-AUG-99
OAKVILLE, ONTARIO, CANADA L6H 5T4 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-
BERTEC CORP.                      510(k) NO: K991642(ABBREVIATED)
ATTN: DOUG  MORR                  PHONE NO : 614-430-5421
6185 HUNTLY ROAD                  SE DECISION MADE: 03-AUG-99
SUITE B                           510(k) STATEMENT
WORTHINGTON, OH 43229

DEVICE: BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TES
BINAX, INC.                       510(k) NO: K991726(TRADITIONAL)
ATTN: PAMELA S ANGELL             PHONE NO : 207-772-3988
217 READ ST.                      SE DECISION MADE: 27-AUG-99
PORTLAND, ME 04103                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
BIO-RAD LABORATORIES, INC.        510(k) NO: K992550(TRADITIONAL)
ATTN: ELIZABETH  PLATT            PHONE NO : 949-598-1285
9500 JERONIMO RD.                 SE DECISION MADE: 11-AUG-99
IRVINE, CA 92618-2017             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ELECTRO-NERVE STIMULATOR TENS, MODEL "LX"
BIOMEDICAL LIFE SYSTEMS, INC.     510(k) NO: K990230(ABBREVIATED)
ATTN: RICHARD  SAXON              PHONE NO : 760-727-5600
2448 CADES WAY                    SE DECISION MADE: 19-AUG-99
VISTA, CA 92083                   510(k) STATEMENT

DEVICE: BIPOLAR SHOULDER PROSTHESIS
BIOMET, INC.                      510(k) NO: K991585()
ATTN: FRED  MCCLURE               PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 18-AUG-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: MAXIM REMOVABLE MOLDED POLY TIBIA
BIOMET, INC.                      510(k) NO: K991753(TRADITIONAL)
ATTN: FRED  MCCLURE               PHONE NO : 219-372-1568
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 17-AUG-99
WARSAW, IN 46580                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: LACTOSORB SHEETS
BIOMET, INC.                      510(k) NO: K992158(TRADITIONAL)
ATTN: MICHELLE L MCKINLEY         PHONE NO : 219-267-6639
AIRPORT INDUSTRIAL PARK           SE DECISION MADE: 20-AUG-99
P.O. BOX 587                      510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587

DEVICE: ANATOMICAL BANKART TACK, MODEL 523520A
BIONX IMPLANTS, LTD.              510(k) NO: K992567(SPECIAL)
ATTN: TUIJA  ANNALA               PHONE NO : 358 331 65600
P.O. BOX 3                        SE DECISION MADE: 27-AUG-99
HERMINKATU 6-8L                   510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720

DEVICE: STREP B OIA
BIOSTAR, INC.                     510(k) NO: K991828(TRADITIONAL)
ATTN: ROGER C BRIDEN              PHONE NO : 303-530-3888
6655 LOOKOUT RD.                  SE DECISION MADE: 19-AUG-99
BOULDER, CO 80301                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POST CEMENT HI-X
BISCO, INC.                       510(k) NO: K992248(TRADITIONAL)
ATTN: KATHRYN B PATTERSON         PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD.         SE DECISION MADE: 25-AUG-99
SCHAUMBURG, IL 60193              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
BOSTON SCIENTIFIC/SCIMED          510(k) NO: K992123(TRADITIONAL)
ATTN: MELANIE  RASKA              PHONE NO : 800-553-5878
ONE SCIEMD PLACE                  SE DECISION MADE: 23-AUG-99
MAPLE GROVE, MN 55311-1566        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO F
BUFFALO FILTER CO., INC.          510(k) NO: K983298(TRADITIONAL)
ATTN: CLINTON R HOLLAND JR.       PHONE NO : 716-835-7000
6000 N. BAILEY AVE, SUITE 9       SE DECISION MADE: 16-AUG-99
BUFFALO, NY 14226                 510(k) STATEMENT

DEVICE: BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
BUFFALO FILTER CO., INC.          510(k) NO: K983333(TRADITIONAL)
ATTN: CLINTON R HOLLAND JR        PHONE NO : 716-835-7000
6000 N. BAILEY AVE, SUITE 9       SE DECISION MADE: 11-AUG-99
BUFFALO, NY 14226                 510(k) STATEMENT

DEVICE: BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
BUFFALO FILTER CO., INC.          510(k) NO: K983364(TRADITIONAL)
ATTN: CLINTON R HOLLAND JR.       PHONE NO : 716-835-7000
6000 N. BAILEY AVE, SUITE 9       SE DECISION MADE: 11-AUG-99
BUFFALO, NY 14226                 510(k) STATEMENT

DEVICE: CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY
CANTOR & SILVER LTD.              510(k) NO: K992500(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO : 970-243-5490
623 GLACIER DRIVE                 SE DECISION MADE: 18-AUG-99
GRAND JUNCTION, CO 81503          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CARD GUARD, MODEL CG-6550
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K990478(TRADITIONAL)
ATTN: LEONID  TRACHTENBERG        PHONE NO : 972 894 84600
2 PEKERIS STREET                  SE DECISION MADE: 31-AUG-99
REHOVOT, ISRAEL                   510(k) STATEMENT

DEVICE: TELEMEDICINE 2000
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K992164(SPECIAL)
ATTN: LEONID  TRACHTENBERG        PHONE NO : 972 899 484600
2 PERERIS ST., SCIENCE PARK       SE DECISION MADE: 30-AUG-99
REHOVOT, ISRAEL 76100             510(k) STATEMENT

DEVICE: CARESIDE AMMONIA
CARESIDE, INC.                    510(k) NO: K991371(TRADITIONAL)
ATTN: KENNETH B ASSARCH, PHARM    PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY              SE DECISION MADE: 03-AUG-99
CULVER CITY, CA 90230             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARESIDE MG
CARESIDE, INC.                    510(k) NO: K991717(TRADITIONAL)
ATTN: KENNETH B ASARCH            PHONE NO : 310-338-6767
6100 BRISTOL PARKWAY              SE DECISION MADE: 10-AUG-99
CULVER CITY, CA 90230             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
CENOGENICS CORP.                  510(k) NO: K992397(TRADITIONAL)
ATTN: NITZA  KATZ                 PHONE NO : 732-536-6457
100 RT. 520                       SE DECISION MADE: 26-AUG-99
MORGANVILLE, NJ 07751             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)
CHARTER MEDICAL, LTD.             510(k) NO: K990310(TRADITIONAL)
ATTN: DAVID  HEAGLE               PHONE NO : 732-901-9400
1805 SWARTHMORE AVE.              SE DECISION MADE: 30-AUG-99
LAKEWOOD, NJ 08701                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
CHEMICON INTL., INC.              510(k) NO: K992252(SPECIAL)
ATTN: CINDY  PENNY                PHONE NO : 909-676-8080
28835 SINGLE OAK DRIVE            SE DECISION MADE: 10-AUG-99
TEMECULA, CA 92590                510(k) STATEMENT

DEVICE: CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
CHIRON DIAGNOSTICS CORP.          510(k) NO: K992157(TRADITIONAL)
ATTN: WILLIAM J PIGNATO           PHONE NO : 508-359-3825
63 NORTH ST.                      SE DECISION MADE: 05-AUG-99
MEDFIELD, MA 02052-1688           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DAILIES (NELFILCON A) ONE-DAY
CIBA VISION JOHNS CREEK MFG.      510(k) NO: K992446(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI         PHONE NO : 678-415-3924
11460 JOHNS CREEK PARKWAY         SE DECISION MADE: 18-AUG-99
DULUTH, GA 30097                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
CIRCON CORP.                      510(k) NO: K992126(TRADITIONAL)
ATTN: RONALD J EHMSEN             PHONE NO : 805-961-3290
6500 HOLLISTER AVENUE             SE DECISION MADE: 03-AUG-99
SANTA BARBARA, CA 93117-3019      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF,
CIVCO MEDICAL INSTRUMENTS CO., INC510(k) NO: K992152(TRADITIONAL)
ATTN: J. WILLIAM  JONES           PHONE NO : 319-656-4447
102 FIRST ST. SOUTH               SE DECISION MADE: 17-AUG-99
KALONA, IA 52247                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
COGENT DIAGNOTICS LTD.            510(k) NO: K991890(TRADITIONAL)
ATTN: DANIELLE M KNIGHT           PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK            SE DECISION MADE: 09-AUG-99
BUSH LOAN                         510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL

DEVICE: AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
COGENT DIAGNOTICS LTD.            510(k) NO: K991942(TRADITIONAL)
ATTN: DANIELLE M KNIGHT           PHONE NO : 714-933-3000
PENTLANDS SCIENCE PARK            SE DECISION MADE: 24-AUG-99
BUSH LOAN                         510(k) STATEMENT
EDINBURGH, UNITED KINGDOM EH26 OPL

DEVICE: COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS
COLORSOFT LABORATORIES CORP.      510(k) NO: K992339(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO : 970-243-5490
623 GLACIER DRIVE                 SE DECISION MADE: 16-AUG-99
GRANT JUNCTION, CO 81503          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
CONWAY STUART MEDICAL, INC.       510(k) NO: K990724(TRADITIONAL)
ATTN: THOMAS  WEHMAN              PHONE NO : 408-733-9910
735 PALOMAR ST.                   SE DECISION MADE: 13-AUG-99
SUNNYVALE, CA 94086               510(k) STATEMENT

DEVICE: URETHANE PICC LINE MODEL UPICS-
COOK, INC.                        510(k) NO: K992198(SPECIAL)
ATTN: LISA  WEBB                  PHONE NO : 812-339-2235
925 SOUTH CURRY PIKE              SE DECISION MADE: 27-AUG-99
BLOOMINGTON, IN 47402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSOR
CORDIS CORP.                      510(k) NO: K991028(TRADITIONAL)
ATTN: CHARLES J RYAN              PHONE NO : 908-412-7446
40 TECHNOLOGY DRIVE               SE DECISION MADE: 04-AUG-99
WARREN, NJ 07059                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY
CORDIS CORP.                      510(k) NO: K991674(TRADITIONAL)
ATTN: CHARLES J RYAN              PHONE NO : 908-412-7446
40 TECHNOLOGY DR.                 SE DECISION MADE: 12-AUG-99
WARREN, NJ 07059                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
CORDIS ENDOVASCULAR SYSTEMS, INC. 510(k) NO: K984214(TRADITIONAL)
ATTN: ALINA  CARABALLO            PHONE NO : 305-512-6518
14000 N.W. 57TH CT.               SE DECISION MADE: 10-AUG-99
MIAMI LAKES, FL 33014             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N LATEX STFR REAGENT
DADE BEHRING, INC.                510(k) NO: K991157(TRADITIONAL)
ATTN: CAROLYN K GEORGE            PHONE NO : 781-826-2073
GLASGOW SITE                      SE DECISION MADE: 02-AUG-99
P.O. BOX 6101                     510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714

DEVICE: TRIP TONOMETRY CATHETER, 8F
DATEX-OHMEDA, INC.                510(k) NO: K992181(TRADITIONAL)
ATTN: JOEL  KENT                  PHONE NO : 978-640-0460


TEWKSBURY, MA 01876               510(k) STATEMENT

DEVICE: DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
DENTSPLY INTL.                    510(k) NO: K991909(TRADITIONAL)
ATTN: P. JEFFERY  LEHN            PHONE NO : 717-845-7511
570 WEST COLLEGE AVE              SE DECISION MADE: 20-AUG-99
YORK, PA 17404                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
DENTSPLY INTL.                    510(k) NO: K992516(TRADITIONAL)
ATTN: P. JEFFERY  LEHN            PHONE NO : 717-845-7511
570 WEST COLLEGE AVE              SE DECISION MADE: 27-AUG-99
YORK, PA 17404                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
DERMAPHYLYX, INC.                 510(k) NO: K991920(TRADITIONAL)
ATTN: ANDREW M REED               PHONE NO : 303-431-6796
12106, WEST 75TH LANE             SE DECISION MADE: 12-AUG-99
ARVADA, CO 80005-5306             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: POCKIT HSV 2 RAPI  D TEST
DIAGNOLOGY LTD.                   510(k) NO: K983886(TRADITIONAL)
ATTN: ROBERT  SCHIFF              PHONE NO : 973-227-1830
1129 BLOOMFIELD AVENUE            SE DECISION MADE: 19-AUG-99
WEST CALDWELL, NJ 07006           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARAMED PARAFFIN WARMER
DIVI INTL. CO.                    510(k) NO: K991427(TRADITIONAL)
ATTN: MIKE  VIDAL                 PHONE NO : 305-253-9200
12188 S.W. 128TH ST.              SE DECISION MADE: 13-AUG-99
MIAMI, FL 33186                   510(k) STATEMENT

DEVICE: ATC OPTION FOR EVITA 2 DURA AND EVITA 4
DRAGER, INC.                      510(k) NO: K992608(SPECIAL)
ATTN: HARALD  KNEUER              PHONE NO : 215-721-6910
3136 QUARRY RD.                   SE DECISION MADE: 24-AUG-99
TELFORD, PA 18969                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: DUTECK DIGITAL CLINICAL THERMOMETER
DUTECK INDUSTRIAL CO., LTD.       510(k) NO: K992327(TRADITIONAL)
ATTN: ALLEN  REICH                PHONE NO : 520-773-9488
900 N. SWITZER DR. #142           SE DECISION MADE: 18-AUG-99
FLAGGSTAFF, AZ 86001              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBI OMEGA 21 SYSTEM
EBI ELECTRO BIOLOGY               510(k) NO: K991721(TRADITIONAL)
ATTN: JONAS  WILF                 PHONE NO : 973-299-9022
100 INTERPACE PARKWAY             SE DECISION MADE: 13-AUG-99
PARSIPPANY, NJ 07054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBI XFIX DFS OPTIROM ELBOW FIXATOR
EBI, L.P.                         510(k) NO: K992515(SPECIAL)
ATTN: JONAS  WILF                 PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 17-AUG-99
PARSIPPANY, NJ 07054-1079         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTERMITTENT COMPRESSION BOOT FOR OTC
EISCHOCO, INC.                    510(k) NO: K991921(TRADITIONAL)
ATTN: JACK  SPEER                 PHONE NO : 801-582-6470
1232 S.E. 282ND AVENUE            SE DECISION MADE: 13-AUG-99
GRESHAM, OR 97080                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNAWELL OR DYNAWELL
EKEROTH QUALITY AB                510(k) NO: K992120(TRADITIONAL)
ATTN: NILS  EKEROTH               PHONE NO :
NYBROKAJEN 7                      SE DECISION MADE: 13-AUG-99
STOCKHOLM, SWEDEN 102 41          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KI
ELAN DIAGNOSTICS                  510(k) NO: K992029(TRADITIONAL)
ATTN: WYNN  STOCKING              PHONE NO : 714-871-8360
231 NORTH PUENTE ST.              SE DECISION MADE: 12-AUG-99
BREA, CA 92821                    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EBI XFIX DFS RAIL SYSTEM
ELECTRO-BIOLOGY, INC.             510(k) NO: K991941(TRADITIONAL)
ATTN: JONAS  WILF                 PHONE NO : 973-299-9022
100 INTERPACE PKWY.               SE DECISION MADE: 19-AUG-99
PARSIPPANY, NJ 07054              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
ELGEMS, LTD.                      510(k) NO: K991841(TRADITIONAL)
ATTN: DAN  LAOR                   PHONE NO : 972 485 63666
P.O. BOX 170                      SE DECISION MADE: 26-AUG-99
TIRAT HACARMEL, ISRAEL 30200      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANG
ELGEMS, LTD.                      510(k) NO: K991896(TRADITIONAL)
ATTN: LAOR  DAN                   PHONE NO : 972 483 10335
P.O. BOX 170                      SE DECISION MADE: 23-AUG-99
TIRAT HACARMEL, ISRAEL 30200      510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ULTIMAX ANKLE FUSION ROD SYSTEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K991790(TRADITIONAL)
ATTN: DEBBIE DE LOS  SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 06-AUG-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ULTIMAX HAIG II NAIL SYSTEM
ENCORE ORTHOPEDICS, INC.          510(k) NO: K991889(TRADITIONAL)
ATTN: DEBBIE  DE LOS SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 12-AUG-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENCORE FULLY COATED HIP
ENCORE ORTHOPEDICS, INC.          510(k) NO: K992109(TRADITIONAL)
ATTN: DEBBIE DE LOS  SANTOS       PHONE NO : 512-834-6237
9800 METRIC BLVD.                 SE DECISION MADE: 12-AUG-99
AUSTIN, TX 78758                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSCOPIC SPINAL ACCESS SYSTEM
ENDIUS INC.                       510(k) NO: K991794(TRADITIONAL)
ATTN: SUSAN  FINNERAN             PHONE NO : 508-643-0983
23 WEST BACON ST.                 SE DECISION MADE: 13-AUG-99
PLAINVILLE, MA 02762              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ENDOSONICS TRAK BACK DEVICE
ENDOSONICS CORP.                  510(k) NO: K990271(TRADITIONAL)
ATTN: RICHARD  HEBERT             PHONE NO : 916-638-8008
2870 KILGORE RD.                  SE DECISION MADE: 30-AUG-99
RANCHO CORDOVA, CA 95670          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
ESC MEDICAL SYSTEMS, INC.         510(k) NO: K991628(TRADITIONAL)
ATTN: ZVI  LADIN                  PHONE NO : 972 495 99000
YOKNEAM INDUSTRIAL PARK           SE DECISION MADE: 09-AUG-99
PO BOX 240                        510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM, ISRAEL 20692

DEVICE: MODIFICATION OF PROMPT L-POP
ESPE DENTAL AG                    510(k) NO: K992048(TRADITIONAL)
ATTN: ANDREAS  PETERMANN          PHONE NO : 011 498 1527001395
ESPE PLATZ                        SE DECISION MADE: 16-AUG-99
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAN
ETHICON ENDO-SURGERY, INC.        510(k) NO: K991980(TRADITIONAL)
ATTN: TAMIMA  ITANI               PHONE NO : 513-483-8205
4545 CREEK RD.                    SE DECISION MADE: 17-AUG-99
CINCINNATI, OH 45242-2839         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
EUROMED, INC.                     510(k) NO: K992363(SPECIAL)
ATTN: MARY  MCNAMARA-CULLINANE    PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 12-AUG-99
NORTH ATTLEBORO, MA 02760         510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
EXCEL TECH. LTD.                  510(k) NO: K991903(TRADITIONAL)
ATTN: JOHN R MUMFORD              PHONE NO : 905 829 5300
2892 PORTLAND DR.                 SE DECISION MADE: 04-AUG-99
OAKVILLE, ONTARIO, CANADA L6H  5W8510(k) STATEMENT

DEVICE: XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
EXCEL TECH. LTD.                  510(k) NO: K992313(TRADITIONAL)
ATTN: JOHN R MUMFORD              PHONE NO : 905 829 5300
2892 PORTLAND DR.                 SE DECISION MADE: 19-AUG-99
OAKVILLE, ONTARIO, CANADA L6H  5W8510(k) STATEMENT

DEVICE: FERRIS POLYOSTOMY STERILE WOUND DRESSING
FERRIS MFG. CORP.                 510(k) NO: K991729(TRADITIONAL)
ATTN: THEODORE  THORSEN           PHONE NO : 630-887-9797
16 WEST 300 83RD ST.              SE DECISION MADE: 27-AUG-99
BURR RIDGE, IL 60521              510(k) STATEMENT

DEVICE: FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
FIBER IMAGING TECHNOLOGIES, INC.  510(k) NO: K992040(TRADITIONAL)
ATTN: JOSEPH  RESS                PHONE NO : 617-965-7714
45 PONTIAC ROAD                   SE DECISION MADE: 06-AUG-99
NEWTON, MA 02468                  510(k) STATEMENT

DEVICE: FOTONA NOVALIS ER: YAG LASER SYSTEM
FOTONA D.D.                       510(k) NO: K991632(TRADITIONAL)
ATTN: MOJCA  VALIJAVEC            PHONE NO : 386 611 511215
STEGNE 7,                         SE DECISION MADE: 10-AUG-99
LJUBLJANA, SLOVENIA 1210          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FOTONA NOVALIS R RUBY LASER SYSTEM
FOTONA D.D.                       510(k) NO: K991634(TRADITIONAL)
ATTN: MOJCA  VALIJAVEC            PHONE NO : 386 611 511215
STEGNE 7,                         SE DECISION MADE: 10-AUG-99
LJUBLJANA, SLOVENIA 1210          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODI
FRESENIUS USA, INC.               510(k) NO: K992275(SPECIAL)
ATTN: VIRGINIA  SINGER            PHONE NO : 925-688-0990
110 MASON CR                      SE DECISION MADE: 04-AUG-99
CONCORD, CA                       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FURLONG INDUSTRIES                510(k) NO: K991757(TRADITIONAL)
ATTN: PETE  FURLONG               PHONE NO : 847-548-6831
311 N. SLUSSER STREET             SE DECISION MADE: 12-AUG-99
GRAYSLAKE, IL 60030               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
GALLINI U.S., LLC                 510(k) NO: K992499(TRADITIONAL)
ATTN: PAUL L HAWTHORNE            PHONE NO : 800-281-0908
3991 GLENSIDE DR., SUITE F        SE DECISION MADE: 12-AUG-99
RICHMOND, VA 23229                510(k) STATEMENT

 
DEVICE: CHOLESITE TEST SYSTEM
GDS TECHNOLOGY, INC.              510(k) NO: K992132(TRADITIONAL)
ATTN: KEITH  CRAWFORD             PHONE NO : 219-264-7384
25235 LEER DR.                    SE DECISION MADE: 20-AUG-99
ELKHART, IN 46514                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991735(TRADITIONAL)
ATTN: DAVID  WAHLIG               PHONE NO : 414-362-2090
8200 WEST TOWER AVE.              SE DECISION MADE: 19-AUG-99
MILWAUKEE, WI 53223               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K991739(TRADITIONAL)
ATTN: MARIA VITUG  FOUTS          PHONE NO : 800-851-6525
200 HARRY S. TRUMAN, PARKWAY      SE DECISION MADE: 19-AUG-99
SUITE 220                         510(k) SUMMARY AVAILABLE FROM FDA
ANNAPOLIS, MD 21401

DEVICE: GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EX
GE MEDICAL SYSTEMS, INC.          510(k) NO: K991629(TRADITIONAL)
ATTN: LARRY  KROGER               PHONE NO : 414-544-3894
P.O. BOX 414                      SE DECISION MADE: 02-AUG-99
MILWAUKEE, WI 53201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
GEIGER MEDICAL TECHNOLOGIES, INC. 510(k) NO: K992149(TRADITIONAL)
ATTN: JOHN  BOTTJER               PHONE NO : 949-240-7584
24040 CAMINO DEL AVION, A-195     SE DECISION MADE: 19-AUG-99
MONARCH BEACH, CA 92629           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
GENERAL ELECTRIC MEDICAL SYSTEMS  510(k) NO: K992066(TRADITIONAL)
ATTN: LARRY A KROGER              PHONE NO : 414-544-3894
3000 N GRANDVIEW BLVD             SE DECISION MADE: 30-AUG-99
WAUKESHA, WI 53188                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
GENERAL GLOVES CORP.              510(k) NO: K992107(TRADITIONAL)
ATTN: DAVID  HU                   PHONE NO : 510-732-9623
3423 INVESTMENT BLVD              SE DECISION MADE: 23-AUG-99
SUITE 12                          510(k) SUMMARY AVAILABLE FROM FDA
HAYWARD, CA 94545

DEVICE: GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
GENTELL                           510(k) NO: K990440(TRADITIONAL)
ATTN: MARK L ITZKOFF              PHONE NO : 202-776-7800
1667 K ST. N.W., SUITE 700        SE DECISION MADE: 12-AUG-99
WASHINGTON, DC 20006-1608         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JETSONIC 2000
GREEN RIVER, INC.                 510(k) NO: K990545(TRADITIONAL)
ATTN: CESAR  CORAL                PHONE NO : 954-733-4300
5101 N.W. 21ST AVE., SUITE 141    SE DECISION MADE: 11-AUG-99
FORT LAUDERDALE, FL 33309         510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: KANGNIAN BRAND ACUPUNCTURE NEEDLE
HELIO MEDICAL SUPPLIES, INC.      510(k) NO: K991507(TRADITIONAL)
ATTN: YI-FEN  CHANG               PHONE NO : 408-748-9585
2080A WALSH AVE.                  SE DECISION MADE: 27-AUG-99
SANTA CLARA, CA 95050             510(k) STATEMENT

DEVICE: ACUMASTER BRAND ACUPUNCTURE NEEDLE
HELIO MEDICAL SUPPLIES, INC.      510(k) NO: K991508(TRADITIONAL)
ATTN: YI-FEN  CHANG               PHONE NO : 408-748-9585
2080A WALSH AVE.                  SE DECISION MADE: 27-AUG-99
SANTA CLARA, CA 95050             510(k) STATEMENT

DEVICE: VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
HEMAGEN DIAGNOSTICS, INC.         510(k) NO: K992224(TRADITIONAL)
ATTN: JOSEPH M CALIFANO           PHONE NO : 781-890-3766
40 BEAR HILL ROAD                 SE DECISION MADE: 30-AUG-99
WALTHAM, MA 02451                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
HEMAGEN DIAGNOSTICS, INC.         510(k) NO: K992241(TRADITIONAL)
ATTN: JOSEPH M CALIFANO           PHONE NO : 781-890-3766
40 BEAR HILL ROAD                 SE DECISION MADE: 30-AUG-99
WALTHAM, MA 02451                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
HEMAGEN DIAGNOSTICS, INC.         510(k) NO: K992243(TRADITIONAL)
ATTN: JOSEPH M CALIFANO           PHONE NO : 781-890-3766
40 BEAR HILL ROAD                 SE DECISION MADE: 30-AUG-99
WALTHAM, MA 02451                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT
HEMOCLEANSE, INC.                 510(k) NO: K984546(TRADITIONAL)
ATTN: STEPHEN R ASH               PHONE NO : 765-463-9540
2700 KENT AVE.                    SE DECISION MADE: 13-AUG-99
WEST LAFAYETTE, IN 47906          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M350
HEWLETT-PACKARD CO.               510(k) NO: K991871(TRADITIONAL)
ATTN: WARREN R WALTERS            PHONE NO : 515-244-1212
2500 BELL AVE.                    SE DECISION MADE: 05-AUG-99
DES MOINES, IA 50321              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
HEWLETT-PACKARD CO.               510(k) NO: K992636(SPECIAL)
ATTN: MIKE  HUDON                 PHONE NO : 978-659-3173
3000 MINUTEMAN RD.                SE DECISION MADE: 31-AUG-99
ANDOVER, MA 01810-1099            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
HOWMEDICA OSTEONICS CORP.         510(k) NO: K991055(TRADITIONAL)
ATTN: MARYBETH  NAUGHTON          PHONE NO : 201-934-4376
59 ROUTE 17                       SE DECISION MADE: 27-AUG-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
HOWMEDICA OSTEONICS CORP.         510(k) NO: K992025(TRADITIONAL)
ATTN: MARYBETH  NAUGHTON          PHONE NO : 201-934-4376
59 ROUTE 17                       SE DECISION MADE: 13-AUG-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KINEMATIC II ROTATING HINGE KNEE
HOWMEDICA OSTEONICS CORP.         510(k) NO: K992346(SPECIAL)
ATTN: KAREN  ARIEMMA              PHONE NO : 201-760-8187
59 ROUTE 17                       SE DECISION MADE: 12-AUG-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
HOWMEDICA OSTEONICS CORP.         510(k) NO: K992462(TRADITIONAL)
ATTN: KATE  SUTTON                PHONE NO : 201-934-4386
59 ROUTE 17                       SE DECISION MADE: 13-AUG-99
ALLENDALE, NJ 07401-1677          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EASY-CURE (CURING AND WHITENING LIGHT)
ICS OF NORTH AMERICA, INC.        510(k) NO: K992357(TRADITIONAL)
ATTN: ALAN A CREAMER              PHONE NO : 619-558-9203
10054 MESA RIDGE CT.              SE DECISION MADE: 30-AUG-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: REMOTE INTRODUCER, MODEL PI-1000
IMAGE-GUIDED NEUROLOGICS, INC.    510(k) NO: K990907(TRADITIONAL)
ATTN: MICHAEL J RENNER            PHONE NO : 407-757-8990
2290 EAU GALLIE BLVD              SE DECISION MADE: 12-AUG-99
MELBOURNE, FL 32935               510(k) STATEMENT

DEVICE: NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
IMAGE-GUIDED NEUROLOGICS, INC.    510(k) NO: K992304(TRADITIONAL)
ATTN: MICHAEL J RENNER            PHONE NO : 407-757-8990
2290 EAU GALLIE BLVD.             SE DECISION MADE: 27-AUG-99
MELBOURNE, FL 32935               510(k) STATEMENT

DEVICE: INVIGRA PLUS (WITH  SPERMICIDAL LUBRICANT)
INDUS MEDICARE LTD.               510(k) NO: K992438(ABBREVIATED)
ATTN: P.K.  REDDY                 PHONE NO : 91 407 760241
144, S.P. RD., BEGUMPET           SE DECISION MADE: 02-AUG-99
HYDERABAD ANDHRA PRADESH, INDIA 50510(k) STATEMENT

DEVICE: REPOSE BONE SCREW SYSTEM
INFLUENCE, INC.                   510(k) NO: K981677(TRADITIONAL)
ATTN: JONATHAN S KAHAN, ESQ.      PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 27-AUG-99
WASHINGTON, DC 20004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
INFLUENCE, INC.                   510(k) NO: K991792(TRADITIONAL)
ATTN: JONATHAN S KAHAN            PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W.       SE DECISION MADE: 12-AUG-99
WASHINGTON, DC 20004              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: INNERDYNE RADIALLY EXPANDING DILATION, "RED" DEVICE
INNERDYNE, INC.                   510(k) NO: K990854(TRADITIONAL)
ATTN: RICK  GAYKOWSKI             PHONE NO : 801-350-3600
5060 WEST AMELIA EARHART DR.      SE DECISION MADE: 02-AUG-99
SALT LAKE CITY, UT 84116          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MACMED PAEDIATRIC INTRAMEDULLARY NAIL
INNERVISION, INC.                 510(k) NO: K991877(TRADITIONAL)
ATTN: FRANK M LEWIS               PHONE NO : 901-682-0417
6258 SHADY GROVE RD. EAST         SE DECISION MADE: 06-AUG-99
MEMPHIS, TN 38120                 510(k) STATEMENT

DEVICE: CAPHOSOL ARTIFICIAL SALIVA
INPHARMA A.S.                     510(k) NO: K991938(TRADITIONAL)
ATTN: BRUCE R MANNING             PHONE NO : 508-393-3100
P.O. BOX 809, 27 SOUTH STREET     SE DECISION MADE: 10-AUG-99
NORTHBOROUGH, MA 01532            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROTOSNARE
INSCOPE, LLC                      510(k) NO: K992477(TRADITIONAL)
ATTN: AL  WEISENBORN              PHONE NO : 305-829-3437
19526 EAST LAKE DRIVE             SE DECISION MADE: 24-AUG-99
MIAMI, FL 33015                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VEN
INSTRUMENTATION INDUSTRIES, INC.  510(k) NO: K991785(TRADITIONAL)
ATTN: TRICIA  WOOD                PHONE NO : 412-854-1133
2990 INDUSTRIAL BLVD.             SE DECISION MADE: 17-AUG-99
BETHEL PARK, PA 15102             510(k) STATEMENT

DEVICE: TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,S
INSTRUMENTS FOR MEDICINE AND DIAGN510(k) NO: K992508(TRADITIONAL)
ATTN: TRACY S BEST                PHONE NO : 801-972-0500
3959 WEST 1820 SOUTH              SE DECISION MADE: 19-AUG-99
SALT LAKE CITY, UT 84104          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
INTEGRA NEUROCARE LLC             510(k) NO: K992006(TRADITIONAL)
ATTN: NANCY A MATHEWSON           PHONE NO : 858-455-1115
5955 PACIFIC CENTER BLVD.         SE DECISION MADE: 17-AUG-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OSTEOPLAST, MODEL POP200
INTERPORE CROSS INTL.             510(k) NO: K991854(TRADITIONAL)
ATTN: LYNN  RODARTI               PHONE NO : 949-453-3200
181 TECHNOLOGY DR.                SE DECISION MADE: 26-AUG-99
IRVINE, CA 92618-2402             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRASTENT
INTRATHERAPEUTICS, INC.           510(k) NO: K991929(SPECIAL)
ATTN: CATHY  YOHNK                PHONE NO : 612-697-2003
651 CAMPUS DR.                    SE DECISION MADE: 04-AUG-99
ST. PAUL, MN 55112-3495           510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
INTRAVASCULAR RESEARCH LTD.       510(k) NO: K982208(TRADITIONAL)
ATTN: LOUISE C MYERS              PHONE NO : 425-867-0892
14808 N.E. 66TH STREET            SE DECISION MADE: 27-AUG-99
REDMOND, WA 98052-4712            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
INVACARE CORP.                    510(k) NO: K991119(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440-329-6595
1200 TAYLOR ST.                   SE DECISION MADE: 19-AUG-99
ELYRIA, OH 44035                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
INVACARE CORP.                    510(k) NO: K992052(TRADITIONAL)
ATTN: EDWARD A KROLL              PHONE NO : 440-329-6595
ONE INVACARE WAY                  SE DECISION MADE: 12-AUG-99
P.O. BOX 4028                     510(k) SUMMARY AVAILABLE FROM FDA
ELYRIA, OH 44036-2125

DEVICE: TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & L
JAKOUBEK MEDIZINTECHNIK GMBH      510(k) NO: K990785(TRADITIONAL)
ATTN: DOUGLAS  HULFISH            PHONE NO : 847-670-8293
1822 N. STRATFORD RD.             SE DECISION MADE: 27-AUG-99
ARLINGTON HTS., IL 60004          510(k) STATEMENT

DEVICE: JMS A. V. FISTULA NEEDLE SET
JMS CO., LTD.                     510(k) NO: K990470(TRADITIONAL)
ATTN: TETSUHARU  HIROSE           PHONE NO : 818 224 35806
12-17, KAKO-MACHI, NAKA-KU        SE DECISION MADE: 30-AUG-99
HIROSHIMA, JAPAN 730-8652         510(k) STATEMENT

DEVICE: JMS APHERESIS NEEDLE
JMS CO., LTD.                     510(k) NO: K990510(TRADITIONAL)
ATTN: TETSUHARU  HIROSE           PHONE NO : 81 82 2435806
12-17, KAKO-MACHI, NAKA-KU        SE DECISION MADE: 30-AUG-99
HIROSHIMA, JAPAN 730-8652         510(k) STATEMENT

DEVICE: MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
JMS CO., LTD.                     510(k) NO: K991904(TRADITIONAL)
ATTN: KEISUKE  URATOMI            PHONE NO : 818 224 35806
12,17,KAKO-MACHI,NAKA-KU          SE DECISION MADE: 31-AUG-99
HIROSHIMA, 730, JAPAN             510(k) STATEMENT

DEVICE: MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS,
JOHNSON & JOHNSON MEDICAL, DIV. OF510(k) NO: K990236(TRADITIONAL)
ATTN: LINDA G HILL                PHONE NO : 817-262-4791
2500 EAST ARBROOK BLVD.           SE DECISION MADE: 20-AUG-99
ARLINGTON, TX 76014-3631          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: JOSTRA HL-20 TWIN PUMP
JOSTRA USA                        510(k) NO: K984338(TRADITIONAL)
ATTN: KATHY  JOHNSON              PHONE NO : 877-567-8722
478 MEDIA ROAD                    SE DECISION MADE: 19-AUG-99
OXFORD, PA 19363                  510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: KSEA CALCUSPLIT
KARL STORZ ENDOSCOPY              510(k) NO: K992114(TRADITIONAL)
ATTN: KEVIN A KENNAN              PHONE NO : 310-338-8100
600 CORPORATE POINTE              SE DECISION MADE: 18-AUG-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: LAPAROCAM
KARL STORZ ENDOSCOPY              510(k) NO: K992541(TRADITIONAL)
ATTN: KEVIN  KENNAN               PHONE NO : 310-410-2769
600 CORPORATE POINTE              SE DECISION MADE: 19-AUG-99
CULVER CITY, CA 90230-7600        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
KATECHO, INC.                     510(k) NO: K991007(TRADITIONAL)
ATTN: LORNE  SCHARNBERG           PHONE NO : 515-244-1212
2500 BELL AVE.                    SE DECISION MADE: 23-AUG-99
DES MOINES, IA 50321              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DIGITAL VIDEO RECORDING SYSTEM
KAY ELEMETRICS CORP.              510(k) NO: K991738(TRADITIONAL)
ATTN: WILLIAM D HARBESON          PHONE NO : 973-628-6200
2 BRIDGEWATER LN.                 SE DECISION MADE: 13-AUG-99
LINCOLN PARK, NJ 07035-1488       510(k) STATEMENT

DEVICE: KELLER VITAL SIGNS MONITOR, KMS 890+
KELLER MEDICAL SPECIALTIES PRODUCT510(k) NO: K990648(TRADITIONAL)
ATTN: JEAN  WAGNER                PHONE NO : 847-395-3547
42609 CRAWFORD RD                 SE DECISION MADE: 10-AUG-99
ANTIOCH, IL 60002                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: BELLEGLAZE
KERR DENTAL MATERIALS CENTER      510(k) NO: K992067(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVE.            SE DECISION MADE: 27-AUG-99
ORANGE, CA 92667                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
KIEL LABORATORIES, INC.           510(k) NO: K991958(TRADITIONAL)
ATTN: TANYJA  PORCHA              PHONE NO : 770-534-0079
2225 CENTENNIAL DRIVE             SE DECISION MADE: 13-AUG-99
GAINESVILLE, GA 30504             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: KMI WRIST FUSION SYSTEM
KINETIKOS MEDICAL, INC.           510(k) NO: K991873(TRADITIONAL)
ATTN: MICHAEL  COLLINS            PHONE NO : 619-558-2233
4115 SORRENTO VALLEY BLVD.        SE DECISION MADE: 17-AUG-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: K-L-W INTRAORAL DISTRACTOR
KLS-MARTIN L.P.                   510(k) NO: K991875(TRADITIONAL)
ATTN: ED  RANSOM                  PHONE NO : 813-376-4154
3234 ELLA LANE                    SE DECISION MADE: 18-AUG-99
NEW PORT RICHEY, FL 34655         510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: KONICA DIRECT DIGITIZER, MODEL DD-341
KONICA CORP.                      510(k) NO: K990359(TRADITIONAL)
ATTN: RUSSELL D MUNVES            PHONE NO : 212-490-4100
THE CHRYSLER BUILDING             SE DECISION MADE: 17-AUG-99
405 LEXINGTON AVENUE              510(k) STATEMENT
NEW YORK, NY 10174

DEVICE: POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORE
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K992496(TRADITIONAL)
ATTN: LIM KWAN  HWA               PHONE NO : 603 392 7616
LOT 16632, 5-1/4 MILES,           SE DECISION MADE: 25-AUG-99
JALAN MERU                        510(k) STATEMENT
KELANG, SELANGOR, MALAYSIA 41050

DEVICE: POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K992497(TRADITIONAL)
ATTN: LIM KWAN  HWA               PHONE NO : 603 392 7616
LOT 16632, 5-1/4 MILES,           SE DECISION MADE: 25-AUG-99
JALAN MERU                        510(k) STATEMENT
KELANG, SELANGOR, MALAYSIA 41050

DEVICE: KRONUS OPTIQUANT THYROGLOBULIN KIT
KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K991720(TRADITIONAL)
ATTN: A.P.  DOERSCCHUK            PHONE NO : 800-822-6999
1000 CALLE AMANECER               SE DECISION MADE: 09-AUG-99
SAN CLEMENTE, CA 92673            510(k) STATEMENT

DEVICE: THERADYNE ROVER POWERED WHEELCHAIR
KURT MFG. CO.                     510(k) NO: K982724(ABBREVIATED)
ATTN: PHIL  SCHLANGEN             PHONE NO : 612-623-4047
1325 QUINCY STREET N.E.           SE DECISION MADE: 12-AUG-99
MINNEAPOLIS, MN 55413             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UROSTYM BIOFEEDBACK AND STIMULATION PROBES
LABORIE MEDICAL TECH CORP.        510(k) NO: K990041(TRADITIONAL)
ATTN: DALE  COLEMAN               PHONE NO : 802-878-1110
310 HURRICANE LANE #2             SE DECISION MADE: 05-AUG-99
WILLISTON, VT 05495               510(k) STATEMENT

DEVICE: LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
LAGLOVE (M) SDN. BHD.             510(k) NO: K990883(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 833 5054
JALAN SIMPANG BALAK, OFF BATU     SE DECISION MADE: 10-AUG-99
13, JALAN CHERAS, 43000 KAJANG    510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR

DEVICE: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
LAGLOVE (M) SDN. BHD.             510(k) NO: K991949(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 833 5054
JALAN SIMPANG BALAK, OFF BATU     SE DECISION MADE: 12-AUG-99
13, JALAN CHERAS, 43000 KAJANG    510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR

 
DEVICE: LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
LAGLOVE (M) SDN. BHD.             510(k) NO: K991950(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 833 35411
JALAN SIMPANG BALAK, OFF BATU     SE DECISION MADE: 12-AUG-99
13, JALAN CHERAS, 43000 KAJANG    510(k) STATEMENT
SELANGOR DARUL EHSAN MALA, MADAGASCAR

DEVICE: LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT L
LAGLOVE (M) SDN. BHD.             510(k) NO: K992019(TRADITIONAL)
ATTN: G.  BASKARAN                PHONE NO : 603 833 5411
LOT 478, JALAN SIMPANG BALAK,     SE DECISION MADE: 05-AUG-99
OFF BATU 13, JALAN CHERAS         510(k) STATEMENT
KAJANG, SELANGOR, D.E., MALAYSIA 43000

DEVICE: PARAGON
LANCER ORTHODONTICS, INC.         510(k) NO: K991481(TRADITIONAL)
ATTN: DOUGLAS D MILLER            PHONE NO : 760-744-5585
253 PAWNEE ST.                    SE DECISION MADE: 11-AUG-99
SAN MARCOS, CA 92069              510(k) STATEMENT

DEVICE: LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGUR
LASERSCOPE                        510(k) NO: K990903(TRADITIONAL)
ATTN: PAUL  HARDIMAN              PHONE NO : 408-943-0636
3052 ORCHARD DR.                  SE DECISION MADE: 27-AUG-99
SAN JOSE, CA 95134-2011           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: B2C HIP SYSTEM
LEPINE GROUPE SPA.                510(k) NO: K992490(TRADITIONAL)
ATTN: DOUGLAS W STUART            PHONE NO : 941-366-1882
962 SOUTH TAMIAMI, STE. 203       SE DECISION MADE: 19-AUG-99
SARASOTA, FL 34326                510(k) STATEMENT

DEVICE: SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
LIBRARY MEDICAL INC.              510(k) NO: K991312(TRADITIONAL)
ATTN: RICHARD A HARTMAN           PHONE NO : 800-711-8055
60 TERENCE DR.                    SE DECISION MADE: 20-AUG-99
PITTSBURGH, PA 15236              510(k) STATEMENT

DEVICE: TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVOR
LINE ONE LABORATORIES             510(k) NO: K991892(TRADITIONAL)
ATTN: ROBERT  GRUBER              PHONE NO : 323-264-8887
1481 EAST 4TH ST.                 SE DECISION MADE: 19-AUG-99
LOS ANGELES, CA 90033             510(k) STATEMENT

DEVICE: BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
LINVATEC CORP.                    510(k) NO: K991715(TRADITIONAL)
ATTN: LAURA  SENEFF               PHONE NO : 727-399-5234
11311 CONCEPT BLVD.               SE DECISION MADE: 06-AUG-99
LARGO, FL 33773-4908              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CAPSULAR SHRINKAGE ELECTRODE
LINVATEC CORP.                    510(k) NO: K991830(TRADITIONAL)
ATTN: LAURA  SENEFF               PHONE NO : 727-392-6464
11311 CONCEPT BLVD.               SE DECISION MADE: 20-AUG-99
LARGO, FL 33773-4908              510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: LUMA LIGHT 2000 CURE LIGHT
LUMA LITE, INC,                   510(k) NO: K992102(TRADITIONAL)
ATTN: JOSEPH  FOREHAND            PHONE NO : 619-318-1251
477 MARINA PARKWAY #400           SE DECISION MADE: 31-AUG-99
CHULA VISTA, CA 91910             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DUET II GLUCOSE CONTROL MONITORING SYSTEM
LXN CORP.                         510(k) NO: K990942(TRADITIONAL)
ATTN: NEDA  RASHTI                PHONE NO : 619-546-7500
6325 LUSK BLVD.                   SE DECISION MADE: 02-AUG-99
SAN DIEGO, CA 92121               510(k) STATEMENT

DEVICE: LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000
LYSTA A/S                         510(k) NO: K992236(TRADITIONAL)
ATTN: GREGERS  LYSTAGER           PHONE NO : 454 495 3000
GAMMELGAARDSVEJ 102               SE DECISION MADE: 27-AUG-99
FARUM, DENMARK DK-3520            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MAGNATEK 30
MAGNA ADVANCED TECHNOLOGIES, INC. 510(k) NO: K991819(TRADITIONAL)
ATTN: ANNIE  VELEZ                PHONE NO : 305-261-2211
7200 N.W. SEVENTH STREET          SE DECISION MADE: 19-AUG-99
MIAMI, FL 33126                   510(k) STATEMENT

DEVICE: MAHE INSTRUMENTS
MAHE INTL., INC.                  510(k) NO: K991426(TRADITIONAL)
ATTN: WINIFRIED  REICH            PHONE NO : 615-385-3545
300 JAMES ROBERTSON PKWY.         SE DECISION MADE: 05-AUG-99
NASHVILLE, TN 37201               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MANUAL WHEELCHAIR
MAJOR MOBILITY PRODUCTS, INC.     510(k) NO: K992035(TRADITIONAL)
ATTN: SCOTT  SCHWEISS             PHONE NO : 281-398-5444
18206 MANCE CT.                   SE DECISION MADE: 12-AUG-99
HOUSTON, TX 77094                 510(k) STATEMENT

DEVICE: HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
MEDIC-AID LTD.                    510(k) NO: K991685(TRADITIONAL)
ATTN: PAUL E DRYDEN               PHONE NO : 317-335-3780
6329 W. WATERVIEW CT.             SE DECISION MADE: 13-AUG-99
MCCORDSVILLE, IN 46055-9501       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64
MEDICAL ADVANCES, INC.            510(k) NO: K991724(TRADITIONAL)
ATTN: THOMAS E TYNES              PHONE NO : 414-258-3808
10437 INNOVATION DR.              SE DECISION MADE: 02-AUG-99
MILWAUKEE, WI 53226               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
MEDICAL ANALYSIS SYSTEMS, INC.    510(k) NO: K992430(TRADITIONAL)
ATTN: SCOT D KINGHORN             PHONE NO : 800-582-3095
542 FLYNN RD.                     SE DECISION MADE: 30-AUG-99
CAMARILLO, CA 93012               510(k) STATEMENT

 
DEVICE: ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
MEDICAL DATA ELECTRONICS, INC.    510(k) NO: K992411(SPECIAL)
ATTN: DAVID M TRUEBLOOD           PHONE NO : 818-768-6411
12720 WENTWORTH ST.               SE DECISION MADE: 18-AUG-99
ARLETA, CA 91331                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
MEDICAL DATA ELECTRONICS, INC.    510(k) NO: K992413(SPECIAL)
ATTN: DAVID M TRUEBLOOD           PHONE NO : 818-768-6411
12720 WENTWORTH ST.               SE DECISION MADE: 19-AUG-99
ARLETA, CA 91331                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDIFIX INC.
MEDIFIX INC.                      510(k) NO: K992483(TRADITIONAL)
ATTN: GEORGE  ALBULESCU           PHONE NO : 847-965-1898
8727 NARRAGANSETT                 SE DECISION MADE: 30-AUG-99
MORTON GROVE, IL 60053-0000       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SE
MEDIMEX HOLFELD GMBH & CO.        510(k) NO: K991719(TRADITIONAL)
ATTN: DONALD F GRABARZ            PHONE NO : 801-233-0075
MID VALLEY PROFESSIONAL PLAZA     SE DECISION MADE: 18-AUG-99
SALT LAKE CITY, UT 84047-7101     510(k) STATEMENT

DEVICE: MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
MEDLINE INDUSTRIES, INC.          510(k) NO: K991559(TRADITIONAL)
ATTN: LARA N SIMMONS              PHONE NO : 847-949-2639
ONE MEDLINE PL.                   SE DECISION MADE: 23-AUG-99
MUNDELEIN, IL 60060-4486          510(k) STATEMENT

DEVICE: MEDTRONIC AVE BRIDGE STENT
MEDTRONIC AVE, INC.               510(k) NO: K992318(SPECIAL)
ATTN: SUSAN  WALTON               PHONE NO : 707-591-7315
2330A CIRCADIAN WAY               SE DECISION MADE: 02-AUG-99
SANTA ROSA, CA 95407-5415         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MEDTRONIC AVE BRIDGE STENT
MEDTRONIC AVE, INC.               510(k) NO: K992569(SPECIAL)
ATTN: SUSAN  WALTON               PHONE NO : 707-591-7315
2330A CIRCADIAN WAY               SE DECISION MADE: 31-AUG-99
SANTA ROSA, CA 95407-5415         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IMMUNOCARD STAT! E. COLI O157:H7
MERIDIAN DIAGNOSTICS, INC.        510(k) NO: K990263(TRADITIONAL)
ATTN: ALLEN D NICKOL              PHONE NO : 513-271-3700
3471 RIVER HILLS DR.              SE DECISION MADE: 09-AUG-99
CINCINNATI, OH 45244              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
METRIKA, INC.                     510(k) NO: K984530(TRADITIONAL)
ATTN: ERIKA B AMMIRATI            PHONE NO : 650-949-2768
575 SHIRLYNN COURT                SE DECISION MADE: 10-AUG-99
LOS ALTOS, CA 94022               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
MICRO MOTORS, INC.                510(k) NO: K991283(TRADITIONAL)
ATTN: KAREN U SALINAS             PHONE NO : 949-262-0411
3722 AVE. SAUSALITO               SE DECISION MADE: 18-AUG-99
IRVINE, CA 92606-1849             510(k) STATEMENT

DEVICE: EQUINOX OCCLUSION BALLOON SYSTEM
MICRO THERAPEUTICS, INC.          510(k) NO: K990487(TRADITIONAL)
ATTN: TOM  DAUGHTERS              PHONE NO : 949-837-3700
2 GOODYEAR                        SE DECISION MADE: 31-AUG-99
IRVINE, CA 92618                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
MICRODIAGNOSTICS, INC.            510(k) NO: K991505(TRADITIONAL)
ATTN: ROY  CHUNG                  PHONE NO : 714-347-0307
28062 FORBES ROAD, SUITE B        SE DECISION MADE: 05-AUG-99
LAGUNA NIGUEL, CA 92677           510(k) STATEMENT

DEVICE: MICRO-STRIP FOR MARIJUANA METABOLITES
MICRODIAGNOSTICS, INC.            510(k) NO: K991516(TRADITIONAL)
ATTN: ROY  CHUNG                  PHONE NO : 949-347-0307
28062 FORBES ROAD, SUITE B        SE DECISION MADE: 05-AUG-99
LAGUNA NIGUEL, CA 92677           510(k) STATEMENT

DEVICE: SILVERSTEIN MICROWICK
MICROMEDICS, INC.                 510(k) NO: K991670(TRADITIONAL)
ATTN: CHARLES  GROTE              PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR.,        SE DECISION MADE: 26-AUG-99
#150                              510(k) STATEMENT
EAGAN, MN 55121

DEVICE: MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCES
MICROMEDICS, INC.                 510(k) NO: K992138(TRADITIONAL)
ATTN: CHARLES  GROTE              PHONE NO : 651-452-1977
1285 CORPORATE CENTER DR.,        SE DECISION MADE: 09-AUG-99
#150                              510(k) STATEMENT
EAGAN, MN 55121

DEVICE: RENACLEAR DIALYZER CLEANING SYSTEM
MINNTECH CORP.                    510(k) NO: K991851(TRADITIONAL)
ATTN: RICHARD M ORMSBEE           PHONE NO : 612-551-2689
14605 28TH AVE. NORTH             SE DECISION MADE: 30-AUG-99
MINNEAPOLIS, MN 55447             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MITAKA POINT SETTER
MITAKA USA, INC.                  510(k) NO: K991989(TRADITIONAL)
ATTN: MAX  STURGIS                PHONE NO : 435-649-2236
2337 LUCKY JOHN DRIVE             SE DECISION MADE: 27-AUG-99
PARK CITY, UT 84060               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
MITEK PRODUCTS                    510(k) NO: K992406(SPECIAL)
ATTN: PAULA E BULGER              PHONE NO : 781-251-2746
60 GLACIER DR.                    SE DECISION MADE: 06-AUG-99
WESTWOOD, MA 02090                510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: NORODYN 8000 SEMG SYSTEM, ND-8000
MYOTRONICS-NOROMED, INC.          510(k) NO: K992439(SPECIAL)
ATTN: FRAY  ADIB                  PHONE NO : 206-243-4214
15425 53RD AVE. SOUTH             SE DECISION MADE: 13-AUG-99
TUKWILA, WA 98188                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SILGEL STC-S
NAGOR LTD.                        510(k) NO: K984029(TRADITIONAL)
ATTN: J.A.  EVANS                 PHONE NO : 44 016 24625556
PO BOX 21 DOUGLAS                 SE DECISION MADE: 05-AUG-99
ISLE OF MAN IM99 1AX              510(k) SUMMARY AVAILABLE FROM FDA
BRITISH ISLES, BRITISH VIRGIN ISLANDS

DEVICE: SUZANNE
NELLCOR PURITAN BENNETT, INC.     510(k) NO: K990565(TRADITIONAL)
ATTN: DARIN  BUSCH                PHONE NO : 612-694-3563
2800 NORTHWEST BLVD.              SE DECISION MADE: 18-AUG-99
MINNEAPOLIS, MN 55441-2625        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: N-395 PULSE OXIMETER, MODEL N-395
NELLCOR PURITAN BENNETT, INC.     510(k) NO: K991823(TRADITIONAL)
ATTN: DAVID A. C.  GREEN          PHONE NO : 760-603-5978
2200 FARADAY AVE.                 SE DECISION MADE: 25-AUG-99
CARLSBAD, CA 92008-7208           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CUTANEOUS (BAR) ELECTRODE
NEURO SUPPLIES, INC.              510(k) NO: K991769(TRADITIONAL)
ATTN: RONALD  LUICH               PHONE NO : 860-442-5650
86 BOSTON POST ROAD               SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385               510(k) STATEMENT

DEVICE: CUTANEOUS (GROUND) ELECTRODE
NEURO SUPPLIES, INC.              510(k) NO: K991770(TRADITIONAL)
ATTN: RONALD  LUICH               PHONE NO : 860-442-5650
86 BOSTON POST ROAD               SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385               510(k) STATEMENT

DEVICE: DIGITAL RING ELECTRDE
NEURO SUPPLIES, INC.              510(k) NO: K991771(TRADITIONAL)
ATTN: RONALD  LUICH               PHONE NO : 860-442-5650
86 BOSTON POST ROAD               SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385               510(k) STATEMENT

DEVICE: CUTANEOUS (DISC) ELECTRODE
NEURO SUPPLIES, INC.              510(k) NO: K991772(TRADITIONAL)
ATTN: RONALD  LUICH               PHONE NO : 860-442-5650
86 BOSTON POST ROAD               SE DECISION MADE: 18-AUG-99
WATERFORD, CT 06385               510(k) STATEMENT

DEVICE: SOLUSTAPLE
NEWDEAL S.A.                      510(k) NO: K991566(TRADITIONAL)
ATTN: NORMAN F ESTRIN             PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE             SE DECISION MADE: 03-AUG-99
POTOMAC, MD 20854                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
NIDEK, INC.                       510(k) NO: K991284(TRADITIONAL)
ATTN: JERRY  TSUTSUMI             PHONE NO : 510-353-7706
47651 WESTINGHOUSE DR.            SE DECISION MADE: 06-AUG-99
FREMONT, CA 94539                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERI
NIPRO MEDICAL CORP.               510(k) NO: K991623(TRADITIONAL)
ATTN: KAELYN  HADLEY              PHONE NO : 606-224-8256
1384 COPPERFIELD COURT            SE DECISION MADE: 09-AUG-99
LEXINGTON, KY 40514-1268          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9
NONIN MEDICAL, INC.               510(k) NO: K982969(TRADITIONAL)
ATTN: RICHARD P BENNETT           PHONE NO : 612-553-9968
2605 FERNBROOK LANE, NORTH        SE DECISION MADE: 12-AUG-99
MINNEAPOLIS, MN 55447-4755        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SUPER PORCELAIN TI-22
NORITAKE CO., INC.                510(k) NO: K992024(TRADITIONAL)
ATTN: MARSHA C WERTZBERGER        PHONE NO : 202-857-6122
1050 CONNECTICUT AVENUE, N.W.     SE DECISION MADE: 27-AUG-99
WASHINGTON, DC 20036-5339         510(k) STATEMENT

DEVICE: BURNFREE PAIN RELIEVING GEL, MODEL 4B
NORTRADE MEDICAL, INC.            510(k) NO: K990178(TRADITIONAL)
ATTN: JAY W TAYLOR                PHONE NO : 801-569-9090
9382 SOUTH 670 WEST               SE DECISION MADE: 13-AUG-99
SANDY, UT 84070                   510(k) STATEMENT

DEVICE: BURNFREE 1/8 OZ. STERILE PAIN RELIEVING GEL, MODEL SD
NORTRADE MEDICAL, INC.            510(k) NO: K990179(TRADITIONAL)
ATTN: JAY W TAYLOR                PHONE NO : 801-569-9090
9382 SOUTH 670 WEST               SE DECISION MADE: 13-AUG-99
SANDY, UT 84070                   510(k) STATEMENT

DEVICE: BURNFREE (4"X4", 8"X8", 16"X24") STERILE BURN & WOUND DRESSING
NORTRADE MEDICAL, INC.            510(k) NO: K990180(TRADITIONAL)
ATTN: JAY W TAYLOR                PHONE NO : 801-569-9090
9382 SOUTH 670 WEST               SE DECISION MADE: 13-AUG-99
SANDY, UT 84070                   510(k) STATEMENT

DEVICE: MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD
NSK NAKANISHI, INC.               510(k) NO: K991701(TRADITIONAL)
ATTN: HIROJI  SEKIGUCHI           PHONE NO : 028 964 3380
340 KAMIHINATA, KANUMA-SHI        SE DECISION MADE: 10-AUG-99
TOCHIGI-KEN, JAPAN 322            510(k) STATEMENT

DEVICE: MINI 6800 DIGITAL MOBILE C-ARM
OEC MEDICAL SYSTEMS, INC.         510(k) NO: K992506(ABBREVIATED)
ATTN: TED L PARROT                PHONE NO : 801-328-9300
384 WRIGHT BROTHERS DR.           SE DECISION MADE: 19-AUG-99
SALT LAKE CITY, UT 84116          510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
OLYMPUS AMERICA, INC.             510(k) NO: K992086(TRADITIONAL)
ATTN: LAURA  STORMS-TYLER         PHONE NO : 516-844-5415
TWO CORPORATE CENTER DR.          SE DECISION MADE: 19-AUG-99
MELVILLE, NY 11042-1179           510(k) STATEMENT

DEVICE: PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-S
OMNIGRACE LTD.                    510(k) NO: K991845(TRADITIONAL)
ATTN: K.C.  CHOONG                PHONE NO : 667 443 9526
641, MOO5 KANCHANAWANIT ROAD      SE DECISION MADE: 05-AUG-99
TAMBON BANPRU                     510(k) STATEMENT
HAT YAI, SONGKHLA, THAILAND 90250

DEVICE: PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STE
OMNIGRACE LTD.                    510(k) NO: K991846(TRADITIONAL)
ATTN: K.C.  CHOONG                PHONE NO : 667 443 9526
641, MOO5 KANCHANAWANIT ROAD      SE DECISION MADE: 05-AUG-99
TAMBON BANPRU                     510(k) STATEMENT
HAT YAI, SONGKHLA, THAILAND 90250

DEVICE: RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A
OPTI-CENTRE LABORATORIES          510(k) NO: K992589(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO : 970-243-5490
623 GLACIER DRIVE                 SE DECISION MADE: 26-AUG-99
GRAND JUNCTION, CO 81503          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: EXPRESSEYE
OPTOMOTOR LABORATORIES            510(k) NO: K992473(TRADITIONAL)
ATTN: BURKHART  FISCHER           PHONE NO : 49 741 2922600
TIVOLISTR. 11                     SE DECISION MADE: 12-AUG-99
D-79104 FREIBURG, GERMANY D-79104 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOF-WATCH S
ORGANON TEKNIKA CORP.             510(k) NO: K992596(SPECIAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 30-AUG-99
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TOF-WATCH SX
ORGANON TEKNIKA CORP.             510(k) NO: K992598(SPECIAL)
ATTN: REBECCA A RIVAS             PHONE NO : 919-620-2288
100 AKZO AVE.                     SE DECISION MADE: 30-AUG-99
DURHAM, NC 27712                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
ORTHO-CLINICAL DIAGNOSTICS, INC.  510(k) NO: K992349(TRADITIONAL)
ATTN: MARLENE A SHULMAN           PHONE NO : 716-453-4041
100 INDIGO CREEK DRIVE            SE DECISION MADE: 24-AUG-99
ROCHESTER, NY 14626-5101          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
OTSUKA PHARMACEUTICAL CO., LTD.   510(k) NO: K991083(TRADITIONAL)
ATTN: JAMES W HARRIS              PHONE NO : 301-527-4719
2440 RESEARCH BLVD                SE DECISION MADE: 20-AUG-99
ROCKVILLE, MD 20850               510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: EXPLORER 3D
OUR SCIENTIFIC INTL., INC.        510(k) NO: K991815(TRADITIONAL)
ATTN: MARIO  CABALLERO            PHONE NO : 925-227-1998
5870 STONERIDGE DRIVE             SE DECISION MADE: 13-AUG-99
PLEASANTVILLE, CA 94588           510(k) STATEMENT

DEVICE: HEPARIN CONTROL PLASMA LEVEL 1
PACIFIC HEMOSTASIS                510(k) NO: K992278(TRADITIONAL)
ATTN: LAURA A WORFOLK             PHONE NO : 704-875-0494
11515 VANSTORY DR.                SE DECISION MADE: 26-AUG-99
HUNTERSVILLE, NC 28078-8144       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HEPARIN CONTROL PLASMA LEVEL 2
PACIFIC HEMOSTASIS                510(k) NO: K992279(TRADITIONAL)
ATTN: LAURA A WORFOLK             PHONE NO : 704-875-0494
11515 VANSTORY DR.                SE DECISION MADE: 26-AUG-99
HUNTERSVILLE, NC 28078-8144       510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF
PALL MEDICAL                      510(k) NO: K992361(TRADITIONAL)
ATTN: LEONARD S BERMAN            PHONE NO : 516-484-5400
2200 NORTHERN BOULEVARD           SE DECISION MADE: 20-AUG-99
EAST HILLS, NY 11548-1209         510(k) STATEMENT

DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLO
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K992165(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH          SE DECISION MADE: 25-AUG-99
SEREMBAN, NAGERI SEMBILAN         510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300

DEVICE: HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION G
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K992223(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH          SE DECISION MADE: 30-AUG-99
SEREMBAN, NAGERI SEMBILAN         510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300

DEVICE: HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION
PAMITEX INDUSTRIES SDN BHD        510(k) NO: K992299(TRADITIONAL)
ATTN: SAID  AWANG                 PHONE NO : 606 631 3122
2 1/2 MILES, JALAN RASAH          SE DECISION MADE: 23-AUG-99
SEREMBAN, NAGERI SEMBILAN         510(k) STATEMENT
DARUL KHUSUS, MALAYSIA 70300

DEVICE: CERSR ELECTROMYOGRAPHY SYSTEM
PAPASPINAL DIAGNOSTIC CO.         510(k) NO: K990766(TRADITIONAL)
ATTN: JOEL S FADEN                PHONE NO : 301-881-9139
11605 HITCHING POST LANE          SE DECISION MADE: 27-AUG-99
ROCKVILLE, MD 20852               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARALLAX TRACER RADIOPAQUE PARTICLES
PARALLAX MEDICAL, INC.            510(k) NO: K991893(TRADITIONAL)
ATTN: SUSAN G MARQUES             PHONE NO : 650-934-6969
453 RAVENDALE DR., SUITE B        SE DECISION MADE: 13-AUG-99
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC.          510(k) NO: K991925(TRADITIONAL)
ATTN: LINDA K DILLON              PHONE NO : 800-321-9813
12750 WEST FORTY-SECOND AVENUE    SE DECISION MADE: 26-AUG-99
WHEAT RIDGEE, CO 80033            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC.          510(k) NO: K992059(TRADITIONAL)
ATTN: LINDA K DILLON              PHONE NO : 303-423-9504
12750 WEST 42ND AVE.              SE DECISION MADE: 30-AUG-99
WHEAT RIDGE, CO 80033             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
PASCO LABORATORIES, INC.          510(k) NO: K992076(TRADITIONAL)
ATTN: LINDA K DILLON              PHONE NO : 303-432-9504
12750 WEST 42ND AVE.              SE DECISION MADE: 30-AUG-99
WHEAT RIDGE, CO 80033             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FUNNEL TROCAR
PATTON MEDICAL CORPORATION        510(k) NO: K992324(TRADITIONAL)
ATTN: MICHAEL T PATTON            PHONE NO : 512-329-0469
1000 WESTBANK DRIVE               SE DECISION MADE: 19-AUG-99
SUITE 5A200                       510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746

DEVICE: O.B. TAMPON
PERSONAL PRODUCTS CO.             510(k) NO: K990536(TRADITIONAL)
ATTN: RALPH  PETRONE              PHONE NO : 908-874-1700
199 GRANDVIEW RD.                 SE DECISION MADE: 31-AUG-99
SKILLMAN, NJ 08558                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNERGY SHOULDER COIL
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K991765(TRADITIONAL)
ATTN: PETER  ALTMAN               PHONE NO : 203-926-7674
710 BRIDGEPORT AVENUE             SE DECISION MADE: 02-AUG-99
P.O. BOX 860                      510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484-0197

DEVICE: MRGP OPTICAL TRACKING UNIT
PICKER INTERNATIONAL, INC.        510(k) NO: K991943(TRADITIONAL)
ATTN: ELAINE K KEELER             PHONE NO : 440-473-5591
595 MINER ROAD                    SE DECISION MADE: 23-AUG-99
HIGHLAND HEIGHTS, OH 44143        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: IPASS BOLUS TRACKING
PICKER INTERNATIONAL, INC.        510(k) NO: K992412(SPECIAL)
ATTN: ELAINE K KEELER             PHONE NO : 440-473-5591
595 MINER RD.                     SE DECISION MADE: 17-AUG-99
HIGHLAND HEIGHTS, OH 44143        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PLANMED SOPHIE AND SOPHIE CLASSIC
PLANMED OY                        510(k) NO: K991826(TRADITIONAL)
ATTN: BOB  PIENKOWSKI             PHONE NO : 630-595-7077
362, BALM COURT                   SE DECISION MADE: 10-AUG-99
WOOD DALE, IL 60191               510(k) STATEMENT

 
DEVICE: PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
PLUS ORTHOPEDICS                  510(k) NO: K990261(TRADITIONAL)
ATTN: HARTMUT  LOCH               PHONE NO : 619-455-2400
3550 GENERAL ATOMICS CT.          SE DECISION MADE: 27-AUG-99
SAN DIEGO, CA 92121-1194          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AUTOHDL CHOLESTEROL REAGENT SET
POINTE SCIENTIFIC, INC.           510(k) NO: K992002(TRADITIONAL)
ATTN: WILLIAM F WALTERS           PHONE NO : 313-383-7220
1025 JOHN A. PAPALAS DR.          SE DECISION MADE: 05-AUG-99
LINCOLN PARK, MI 48146            510(k) STATEMENT

DEVICE: BLULAZE
PREMIER LASER SYSTEMS             510(k) NO: K992620(TRADITIONAL)
ATTN: BETH A ROBERTS              PHONE NO : 317-585-8160
3 MORGAN                          SE DECISION MADE: 20-AUG-99
IRVINE, CA 92718                  510(k) STATEMENT

DEVICE: ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/O
PRINCETON BIOMEDITECH CORP.       510(k) NO: K992422(SPECIAL)
ATTN: JEMO  KANG                  PHONE NO : 800-726-2670
4242 U.S. RT. 1                   SE DECISION MADE: 10-AUG-99
MONMOUTH JUNCTION, NJ 08852-1905  510(k) STATEMENT

DEVICE: QUICKVUE ONE-STEP H. PYLORI II TEST
QUIDEL CORP.                      510(k) NO: K991747(TRADITIONAL)
ATTN: ROBIN  WEINER               PHONE NO : 619-552-7908
10165 MCKELLAR CT.                SE DECISION MADE: 04-AUG-99
SAN DIEGO, CA 92121               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
RADIONICS, INC.                   510(k) NO: K991237(TRADITIONAL)
ATTN: NANCY  MACDONALD            PHONE NO : 718-272-1233
22 TERRY AVE.                     SE DECISION MADE: 30-AUG-99
BURLINGTON, MA 01803              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PARSET, MODEL A10001E
RD MEDICAL MFG., INC.             510(k) NO: K992104(ABBREVIATED)
ATTN: CARLOS A RODRIGUEZ-GARCIA   PHONE NO : 787-742-3800
CALLE ESCUDERO FINAL, BO.         SE DECISION MADE: 23-AUG-99
FULLADOSA                         510(k) SUMMARY AVAILABLE FROM FDA
CUELBRA, PR

DEVICE: REDI-TEST PCP
REDWOOD BIOTECH INC.              510(k) NO: K991698(TRADITIONAL)
ATTN: JANIS  FREESTONE            PHONE NO : 650-691-4770
2440 LEGHORN ST.                  SE DECISION MADE: 25-AUG-99
MOUNTAIN VIEW, CA 94043           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRAINAGE BAG
REMINGTON MEDICAL, INC.           510(k) NO: K990428(TRADITIONAL)
ATTN: STEVE  WOODY                PHONE NO : 770-888-8520
6830 MEADOWRIDGE CT.              SE DECISION MADE: 12-AUG-99
ALPHARETTA, GA 30005              510(k) STATEMENT

 
DEVICE: ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING
RESEARCH INSTRUMENTS LTD.         510(k) NO: K991261(TRADITIONAL)
ATTN: DAVID C LANSDOWNE           PHONE NO : 441 326 372753
KERNICK RD.                       SE DECISION MADE: 05-AUG-99
PENRYN, CORWALL, UNITED KINGDOM TR510(k) STATEMENT

DEVICE: MONARCH II MINI MASK
RESPIRONICS, INC.                 510(k) NO: K992336(SPECIAL)
ATTN: DAVID J VANELLA             PHONE NO : 724-733-5866
1001 MURRY RIDGE DRIVE            SE DECISION MADE: 13-AUG-99
MURRYSVILLE, PA 15668             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
RI MOS. S.R.L.                    510(k) NO: K991895(TRADITIONAL)
ATTN: JAMES  DELANEY              PHONE NO : 978-371-0066
100 MAIN ST.                      SE DECISION MADE: 12-AUG-99
SUITE 120                         510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, MA

DEVICE: RIWO DRIVE GENERATOR
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K984304(TRADITIONAL)
ATTN: ROBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY.         SE DECISION MADE: 12-AUG-99
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 1
RICHARD WOLF MEDICAL INSTRUMENTS C510(k) NO: K991718(TRADITIONAL)
ATTN: ROBERT L CASARSA            PHONE NO : 847-913-1113
353 CORPORATE WOODS PKWY          SE DECISION MADE: 12-AUG-99
VERNON HILLS, IL 60061            510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
ROCHE MOLECULAR SYSTEMS, INC.     510(k) NO: K973707(TRADITIONAL)
ATTN: ALEX  WESOLOWSKI            PHONE NO : 908-253-7540
1080 U.S. HIGHWAY 202             SE DECISION MADE: 04-AUG-99
SOMERVILLE, NJ 08876-3711         510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRAT
ROCKWELL MEDICAL TECHNOLOGIES, INC510(k) NO: K983618(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN          PHONE NO : 612-835-4018
28025 OAKLAND OAKS CT.            SE DECISION MADE: 05-AUG-99
WIXOM, MI 48393                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
RON-TECH MEDICAL LTD.             510(k) NO: K992071(TRADITIONAL)
ATTN: AHAVA  STEIN                PHONE NO : 972 979 20673
P.O. BOX 454                      SE DECISION MADE: 27-AUG-99
GINOT SHOMRON, ISRAEL 44853       510(k) STATEMENT

DEVICE: FLEXIFLO ENTERAL FEEDING TUBE
ROSS PRODUCTS, DIV. ABBOTT LABORAT510(k) NO: K992494(SPECIAL)
ATTN: DANIEL  HAMILTON            PHONE NO : 614-624-3743
                                  SE DECISION MADE: 25-AUG-99
                                  510(k) STATEMENT

 
DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-41
ROSSMAX INTL. LTD.                510(k) NO: K992387(SPECIAL)
ATTN: MICHAEL  YEH                PHONE NO : 011 886 27835584
2F. NO. 10, ALLEY 20 LANE 106     SE DECISION MADE: 03-AUG-99
SECTION 3, NAN KANG ROAD          510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)

DEVICE: ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-42
ROSSMAX INTL. LTD.                510(k) NO: K992388(SPECIAL)
ATTN: MICHAEL  YEH                PHONE NO : 011 886 27835584
2F. NO. 10, ALLEY 20 LANE 106     SE DECISION MADE: 03-AUG-99
SEC 3 NON KANG RD.                510(k) STATEMENT
TAIPEI, CHINA (TAIWAN)

DEVICE: RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNC
RUSCH INTL.                       510(k) NO: K990619(TRADITIONAL)
ATTN: KARENANN J BROZOWSKI        PHONE NO : 603-532-7706
TALL PINES PARK                   SE DECISION MADE: 03-AUG-99
JAFFREY, NH 03452                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAS ADENO TEST
SA SCIENTIFIC, INC.               510(k) NO: K990630(TRADITIONAL)
ATTN: J.  WESSLING                PHONE NO : 210-699-8800
4919 GOLDEN QUAIL                 SE DECISION MADE: 19-AUG-99
SAN ANTONIO, TX 78240             510(k) STATEMENT

DEVICE: SAS ROTA TEST
SA SCIENTIFIC, INC.               510(k) NO: K990842(TRADITIONAL)
ATTN: J.  WESSLING                PHONE NO : 210-699-8800
4919 GOLDEN QUAIL                 SE DECISION MADE: 09-AUG-99
SAN ANTONIO, TX 78240             510(k) STATEMENT

DEVICE: SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
SAFESKIN CORP.                    510(k) NO: K992062(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO         PHONE NO : 619-794-8111
12671 HIGH BLUFF DR.              SE DECISION MADE: 25-AUG-99
SAN DIEGO, CA 92130               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE W
SAFESKIN CORP.                    510(k) NO: K992162(TRADITIONAL)
ATTN: EUGENE V GOORCHENKO         PHONE NO : 619-509-7010
12671 HIGH BLUFF DR.              SE DECISION MADE: 30-AUG-99
SAN DIEGO, CA 92130               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SALTER LABS PEP DEVICE
SALTER LABORATORIES               510(k) NO: K991788(TRADITIONAL)
ATTN: DUANE  KAZAL                PHONE NO : 805-854-3166
100 WEST SYCAMORE RD.             SE DECISION MADE: 06-AUG-99
ARVIN, CA 93203                   510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
SANGSTAT MEDICAL CORP.            510(k) NO: K991594(TRADITIONAL)
ATTN: COLLEEN  STEWART            PHONE NO : 510-789-4540
6300 DUMBARTON CIRCLE             SE DECISION MADE: 05-AUG-99
FREMONT, CA 94555                 510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: FLEXISCOPE IQ 101
SCHOELLY FIBEROPTIC, GMBH         510(k) NO: K992362(TRADITIONAL)
ATTN: JOSEPH  RESS                PHONE NO : 617-965-7714
45 PONTIAC ROAD                   SE DECISION MADE: 05-AUG-99
NEWTON, MA 02248                  510(k) STATEMENT

DEVICE: SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
SECHRIST INDUSTRIES, INC.         510(k) NO: K992503(SPECIAL)
ATTN: GREG  GODFREY               PHONE NO : 714-579-8318
4225 EAST LA PALMA                SE DECISION MADE: 10-AUG-99
ANAHEIM, CA 92807                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SEDATELEC ASP ACUPUNCTURE NEEDLES
SEDATELEC                         510(k) NO: K983798(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100     SE DECISION MADE: 27-AUG-99
PLEASANT HILL, CA 94523-3389      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DN ACUPUNTURE NEEDLES
SEDATELEC                         510(k) NO: K983800(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 925-356-2640
200 GREGORY LANE, SUITE C-100     SE DECISION MADE: 27-AUG-99
PLEASANT HILL, CA 94523-3389      510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
SELTOM PACIFIC SDN. BHD.          510(k) NO: K991776(TRADITIONAL)
ATTN: S.  SEGARAN                 PHONE NO : 603 735 6010
LOT 25, JALAN  PJS 7/17           SE DECISION MADE: 11-AUG-99
SUNWAY INDUSTRIAL PARK            510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150

DEVICE: LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM
SELTOM PACIFIC SDN. BHD.          510(k) NO: K991777(TRADITIONAL)
ATTN: S.  SEGARAN                 PHONE NO : 603 735 6010
LOT 25, JALAN  PJS 7/17           SE DECISION MADE: 31-AUG-99
SUNWAY INDUSTRIAL PARK            510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150

DEVICE: LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
SELTOM PACIFIC SDN. BHD.          510(k) NO: K991778(TRADITIONAL)
ATTN: S.  SEGARAN                 PHONE NO : 603 735 6010
LOT 25, JALAN  PJS 7/17           SE DECISION MADE: 31-AUG-99
SUNWAY INDUSTRIAL PARK            510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150

DEVICE: NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
SELTOM PACIFIC SDN. BHD.          510(k) NO: K991779(TRADITIONAL)
ATTN: S.  SEGARAN                 PHONE NO : 603 735 6010
LOT 25, JALAN  PJS 7/17           SE DECISION MADE: 11-AUG-99
SUNWAY INDUSTRIAL PARK            510(k) STATEMENT
PETALING JAYA, SELANGOR, MALAYSIA 46150

 
DEVICE: INFANT FLOW SYSTEM
SENSORMEDICS CORP.                510(k) NO: K991972(SPECIAL)
ATTN: ALEX  STENZLER              PHONE NO : 800-520-4368
22705 SAVI RANCH PKWY.            SE DECISION MADE: 13-AUG-99
YORBA LINDA, CA 92887-4645        510(k) STATEMENT

DEVICE: URINE DRUG SCREENING CONTROL
SERACARE TECHNOLOGY               510(k) NO: K992395(TRADITIONAL)
ATTN: RUSTY  SEWELL               PHONE NO : 512-445-5100
2170 WOODWARD ST.                 SE DECISION MADE: 26-AUG-99
AUSTIN, TX 78744-1832             510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K992017(TRADITIONAL)
ATTN: JOHN  LAI                   PHONE NO : 011 862 157814213
259 YUSHU RD.,                    SE DECISION MADE: 05-AUG-99
CANGQIAO TOWNSHIP                 510(k) STATEMENT
SONGJIANG SHANGHAI, CHINA

DEVICE: TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GRE
SHEN WEI (USA), INC.              510(k) NO: K992200(TRADITIONAL)
ATTN: BELLE L CHOU                PHONE NO : 510-429-8692
2845 WHIPPLE RD.                  SE DECISION MADE: 17-AUG-99
UNION CITY, CA 94587              510(k) STATEMENT

DEVICE: SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG DILLY PLASTICS PRODUC510(k) NO: K992463(TRADITIONAL)
ATTN: XINGLAI  ZHOU               PHONE NO : 011 863 113830158
NO. 16 ZHI NONG RD.               SE DECISION MADE: 30-AUG-99
SHIJIAZHUANG, CHINA 050051        510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
SIEMENS CORP.                     510(k) NO: K991652(TRADITIONAL)
ATTN: KATHLEEN  RUTHERFORD        PHONE NO : 732-321-4625
186 WOOD AVE., SOUTH              SE DECISION MADE: 03-AUG-99
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOMATOM PROJECT 10-CT SCANNERS
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K991764(TRADITIONAL)
ATTN: ALICIA  JUERGENSEN          PHONE NO : 908-321-3243
186 WOOD AVENUE SOUTH             SE DECISION MADE: 17-AUG-99
ISELIN, NJ 08830                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SYSTEMS, INC.     510(k) NO: K992046(TRADITIONAL)
ATTN: STEVE  HESLER               PHONE NO : 425-557-1629
22010 S.E. 51ST STREET            SE DECISION MADE: 13-AUG-99
ISSAQUAH, WA 98027-7002           510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: GONOSTAT GONOCOCCAL DETECTION KIT
SIERRA DIAGNOSTICS                510(k) NO: K991268(TRADITIONAL)
ATTN: DONALD R STONE              PHONE NO : 202-496-7620
1900 K STREET, N.W.               SE DECISION MADE: 11-AUG-99
WASHINGTON, DC 20006-1108         510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
SIRONA DENTAL SYSTEMS GMBH        510(k) NO: K992644(SPECIAL)
ATTN: SHEILA  HEMEON-HEYER        PHONE NO : 508-643-0434
49 PLAIN STREET                   SE DECISION MADE: 23-AUG-99
NORTH ATTLEBORO, MA 02760-4153    510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: FLUOROPLASTIC VENTILATION TUBES
SMITH & NEPHEW ENT.               510(k) NO: K992222(TRADITIONAL)
ATTN: ALICIA E FARAGE             PHONE NO : 901-373-0200
2925 APPLING RD.                  SE DECISION MADE: 26-AUG-99
BARTLETT, TN 38133                510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE
SMITH & NEPHEW, INC.              510(k) NO: K990666(ABBREVIATED)
ATTN:   JANET  JOHNSON GREEN      PHONE NO : 901-396-2121
1450 BROOKS RD.                   SE DECISION MADE: 06-AUG-99
MEMPHIS, TN 38116                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA
SMV AMERICA                       510(k) NO: K991565(TRADITIONAL)
ATTN: PHIL  VERNON                PHONE NO : 330-425-1340
8380 DARROW RD.                   SE DECISION MADE: 02-AUG-99
TWINSBURG, OH 44087               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: DYNA-LOK PLUS  SPINAL SYSTEM
SOFAMOR DANEK USA,INC.            510(k) NO: K991198(TRADITIONAL)
ATTN: RICHARD W TREHARNE          PHONE NO : 901-396-3133
1800 PYRAMID PLACE                SE DECISION MADE: 27-AUG-99
MEMPHIS, TN 38132                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
SOFTCHROME, INC.                  510(k) NO: K991995(TRADITIONAL)
ATTN: MARTIN  DALSING             PHONE NO :
623 GLACIER DRIVE                 SE DECISION MADE: 27-AUG-99
GRAND JUNCTION, CO 81503          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SOUND VASER SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC   510(k) NO: K991791(TRADITIONAL)
ATTN: WILLIAM W CIMINO            PHONE NO : 303-926-8608
1300 PLAZA COURT NORTH # 203      SE DECISION MADE: 12-AUG-99
LAFAYETTE, CO 80026               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MINIJECT
SPARTAN ULTRASONICS INC.          510(k) NO: K991888(TRADITIONAL)
ATTN: ALDO  EAGLE                 PHONE NO : 636-343-8300
1663 FENTON BUSINESS PARK CT.     SE DECISION MADE: 25-AUG-99
FENTON, MO 63026                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS H
STRYKER ENDOSCOPY                 510(k) NO: K991960(TRADITIONAL)
ATTN: N. MANI  PRAKASH            PHONE NO : 408-567-9100
2590 WALSH AVE.                   SE DECISION MADE: 13-AUG-99
SANTA CLARA, CA 95051             510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: QS DELIVERY SYSTEM
SUB-Q, INC.                       510(k) NO: K991254(TRADITIONAL)
ATTN: DAN W MILLER                PHONE NO : 949-369-5751
1062-D CALLE NEGOCIO              SE DECISION MADE: 23-AUG-99
SAN CLEMENTE, CA 92673            510(k) STATEMENT

DEVICE: INTER-OP METASUL ACETABULAR SYSTEM
SULZER ORTHOPEDICS, INC.          510(k) NO: K974728(TRADITIONAL)
ATTN: MITCHELL A DHORITY          PHONE NO : 512-432-9202
9900 SPECTRUM DR.                 SE DECISION MADE: 03-AUG-99
AUSTIN, TX 78717                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
SURETEX PROPHYLACTICS (INDIA) LTD.510(k) NO: K992081(ABBREVIATED)
ATTN: LON D MCILVAIN              PHONE NO : 334-794-4232
1500 INDUSTRIAL ROAD              SE DECISION MADE: 19-AUG-99
P.O. BOX 1252                     510(k) SUMMARY AVAILABLE FROM FDA
DOTHAN, AL 36302

DEVICE: SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
SURGICAL NAVIGATION SPECIALISTS IN510(k) NO: K992457(TRADITIONAL)
ATTN: CAROL  NAKAGAWA             PHONE NO : 905 672 2100
6509 AIRPORT RD.                  SE DECISION MADE: 27-AUG-99
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND
SWEMED LAB INTERNATIONAL AB       510(k) NO: K991273(TRADITIONAL)
ATTN: EDWARD C WILSON JR.         PHONE NO : 202-637-5839
555 13TH STREET N.W.              SE DECISION MADE: 18-AUG-99
WASHINGTON, DC 20004              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: PRODIGY 4 TRANSLUCENT SHADES
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K992118(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE          SE DECISION MADE: 18-AUG-99
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: NEXUS 2
SYBRON DENTAL SPECIALTIES INC.    510(k) NO: K992160(TRADITIONAL)
ATTN: COLLEEN  BOSWELL            PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE          SE DECISION MADE: 18-AUG-99
ORANGE, CA 92867                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES SPINE                     510(k) NO: K991089(TRADITIONAL)
ATTN: JONATHAN  GILBERT           PHONE NO : 610-647-9700
P.O. BOX 0548                     SE DECISION MADE: 27-AUG-99
1690 RUSSELL ROAD                 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301

DEVICE: H20- TETHERED OPTION
TELEFACTOR CORP.                  510(k) NO: K992291(SPECIAL)
ATTN: JAMES S BRYAN               PHONE NO : 610-825-4555
1094 NEW DEHAVEN AVE.             SE DECISION MADE: 06-AUG-99
WEST CONSHOHOCKEN, PA 19428       510(k) SUMMARY AVAILABLE FROM FDA

 
DEVICE: RADIFOCUS OPTITORQUE
TERUMO MEDICAL CORP.              510(k) NO: K992051(SPECIAL)
ATTN: YUK-TING  LEWIS             PHONE NO : 410-392-7213
125 BLUE BALL RD.                 SE DECISION MADE: 10-AUG-99
ELKTON, MD 21921                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: INTRAVASCULAR ADMINISTRATION SET
THE KIPP GROUP                    510(k) NO: K991932(TRADITIONAL)
ATTN: GARY  WERSCHMIDT            PHONE NO : 909-390-9080
930 WANAMAKER AVE.                SE DECISION MADE: 20-AUG-99
ONTARIO, CA 91761                 510(k) STATEMENT

DEVICE: CTD MARK I TRACTION DEVICE
THERASYS, INC.                    510(k) NO: K991931(TRADITIONAL)
ATTN: EARNIE S PHILPOT            PHONE NO : 937-643-3411
2295 NORTH MORAIN DR.             SE DECISION MADE: 12-AUG-99
MORAINE, OH 45439                 510(k) STATEMENT

DEVICE: ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION G
TILLOTSON HEALTHCARE CORP.        510(k) NO: K992428(TRADITIONAL)
ATTN: THOMAS N TILLOTSON          PHONE NO : 603-472-6600
360 ROUTE 101                     SE DECISION MADE: 09-AUG-99
BEDFORD, NH 03110                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AEQUALIS SHOULDER PROSTHESIS
TORNIER S.A.                      510(k) NO: K980244(TRADITIONAL)
ATTN: DAVID W SCHLERF             PHONE NO : 510-356-2640
1000 BURNETT AVENUE               SE DECISION MADE: 23-AUG-99
SUITE 450                         510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, CA 94520

DEVICE: ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K991766(TRADITIONAL)
ATTN: PAUL  BIGGINS               PHONE NO : 714-730-5000
2441 MICHELLE DR.                 SE DECISION MADE: 10-AUG-99
P.O. BOX 2068                     510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92681-2068

DEVICE: OPART, MODEL MRT-600
TOSHIBA AMERICA MRI, INC.         510(k) NO: K991740(TRADITIONAL)
ATTN: HSU  CHANG                  PHONE NO : 650-872-2722
280 UTAH AVE.                     SE DECISION MADE: 02-AUG-99
SOUTH SAN FRANCISCO, CA 94080-6883510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: AIA-PACK FOLATE ASSAY
TOSOH MEDICS, INC.                510(k) NO: K992365(TRADITIONAL)
ATTN: JUDITH E LOEBEL             PHONE NO : 650-615-4970
347 OYSTER POINT BLVD.,           SE DECISION MADE: 10-AUG-99
SUITE 201                         510(k) STATEMENT
SOUTH SAN FRANCISCO, CA 94080

DEVICE: TOUCH TEAR IGE MICROASSAY KIT
TOUCH SCIENTIFIC, INC.            510(k) NO: K991316(TRADITIONAL)
ATTN: ALAN J TOUCH                PHONE NO : 919-872-4445
3209 GRESHAM LAKE RD.             SE DECISION MADE: 09-AUG-99
SUITE 112                         510(k) STATEMENT
RALEIGH, NC 27615

 
DEVICE: MXU-125 OR TMX-125
TREX MEDICAL CORP.                510(k) NO: K992229(TRADITIONAL)
ATTN: KELVIN  BURROUGHS           PHONE NO : 203-731-8442
36 APPLE RIDGE RD.                SE DECISION MADE: 06-AUG-99
DANBURY, CT 06810                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: TWO RIVERS POWER LIFT/RECLINE CHAIR
TWO RIVERS, LLC                   510(k) NO: K991693(TRADITIONAL)
ATTN: CHRIS  WHITAKER             PHONE NO : 423-626-4990
P.O. BOX 356                      SE DECISION MADE: 17-AUG-99
204 SOTH BROAD STREET             510(k) STATEMENT
NEW TAZEWELL, TN 37825

DEVICE: UM-L20/ UM-L30
UNION MEDICAL ENGENEERING CO., LTD510(k) NO: K982860(TRADITIONAL)
ATTN: ANNIE  VALEZ                PHONE NO : 305-663-9936
8930 S.W. 68TH COURT #H3          SE DECISION MADE: 13-AUG-99
MIAMI, FL 33156                   510(k) STATEMENT

DEVICE: SKIN 2 FORTE SILICONE SHEETING
UNITED HOSPITAL TECHNOLOGIES, INC.510(k) NO: K990651(TRADITIONAL)
ATTN: SAMUEL  SWETLAND            PHONE NO : 954-433-7480
10320 USA TODAY WAY               SE DECISION MADE: 13-AUG-99
MIRAMAR, FL 33025                 510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: UROSURGE SPIRALFLO URETERAL STENT
UROSURGE, INC.                    510(k) NO: K992391(TRADITIONAL)
ATTN: STEVEN J PREISS             PHONE NO : 319-626-5335
2660 CROSSPARK RD.                SE DECISION MADE: 18-AUG-99
CORALVILLE, IA 52241              510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: MONOPOLAR ELECTRODES AND CABLES
US ENDO, INC.                     510(k) NO: K992485(TRADITIONAL)
ATTN: JONEL  MANCIU               PHONE NO :
826 EAGLE DRIVE                   SE DECISION MADE: 27-AUG-99
BENSENVILLE, IL 60106             510(k) STATEMENT

DEVICE: CADPLAN HELIOS OPTION 6.0
VARIAN MEDICAL SYSTEMS, INC.      510(k) NO: K984532(TRADITIONAL)
ATTN: LINDA S NASH                PHONE NO : 650-424-6990
3045 HANOVER STREET               SE DECISION MADE: 09-AUG-99
PALO ALTO, CA 94304-1120          510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
VENTANA, INC.                     510(k) NO: K984567(TRADITIONAL)
ATTN: JUDITH  FREDERICK           PHONE NO : 520-690-2731
3865 NORTH BUSINESS CENTER        SE DECISION MADE: 12-AUG-99
DRIVE                             510(k) SUMMARY AVAILABLE FROM FDA
TUCSON, AZ 85705

DEVICE: VINYL POWDERED EXAM GLOVE / CAT.# 15-020
VITALCARE GROUP, INC.             510(k) NO: K992289(TRADITIONAL)
ATTN: GINGER  TALLEY              PHONE NO : 305-620-4007
15800 N.W. 13TH AVE.              SE DECISION MADE: 04-AUG-99
MIAMI, FL 33169                   510(k) STATEMENT

 
DEVICE: PMS 750 FINGERSWITCH
WALLACH SURGICAL DEVICES, INC.    510(k) NO: K991669(TRADITIONAL)
ATTN: MICHAEL  MALIS              PHONE NO : 203-700-2000
235 EDISON RD.                    SE DECISION MADE: 12-AUG-99
ORANGE, CT 06477                  510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: VHS SUPRACONDYLAR PLATE SYSTEM
WALTER ABENDSCHEIN, M.D.          510(k) NO: K991806(TRADITIONAL)
ATTN: WALTER  ABENDSCHEIN         PHONE NO : 301-656-4317
5530 WISCONSIN AVENUE             SE DECISION MADE: 06-AUG-99
SUITE 705                         510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815

DEVICE: WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
WELLS JOHNSON CO.                 510(k) NO: K991437(TRADITIONAL)
ATTN: KEN  RODENBURG              PHONE NO : 520-298-6069
8000 SOUTH KOLB RD.               SE DECISION MADE: 30-AUG-99
TUCSON, AZ 85706                  510(k) STATEMENT

DEVICE: WHITESIDE BIOMECHANICS SPINAL SYSTEM
WHITESIDE BIOMECHANICS, INC.      510(k) NO: K991678(TRADITIONAL)
ATTN: DEBRA  MEYER                PHONE NO : 314-996-8540
12634 OLIVE BLVD.                 SE DECISION MADE: 12-AUG-99
ST. LOUIS, MO 63141               510(k) SUMMARY AVAILABLE FROM FDA

DEVICE: HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMU
ZEUS SCIENTIFIC, INC.             510(k) NO: K991820(TRADITIONAL)
ATTN: MARK J KOPNITSKY            PHONE NO : 908-526-3744
200 EVANS WAY                     SE DECISION MADE: 12-AUG-99
BRANCHBURG, NJ 08876              510(k) STATEMENT


 
                                                TOTAL 510(k)s THIS PERIOD   326
                                                TOTAL WITH SUMMARIES        211
                                                TOTAL WITH STATEMENTS       115