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510(k)s Final Decisions Rendered for July 2000 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JUL-2000 THROUGH 31-JUL-2000
DEVICE: A&D; MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE
A & D ENGINEERING, INC. 510(k) NO: K002115(TRADITIONAL)
ATTN: JERRY WANG PHONE NO : 408-263-5333
1555 MCCANDLESS DRIVE SE DECISION MADE: 25-JUL-00
MILPITAS, CA 95035 510(k) STATEMENT
DEVICE: O-LAS OPHTHALMIC PHOTODISRUPTOR
A.R.C. LASER AG 510(k) NO: K001511(TRADITIONAL)
ATTN: DANIEL HOEFER PHONE NO : 801-972-1311
2417 SOUTH 3850 WEST SE DECISION MADE: 19-JUL-00
SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
ABBOTT LABORATORIES 510(k) NO: K001616(SPECIAL)
ATTN: CHRISTINE L LIONHOOD PHONE NO : 847-935-2531
DEPT. 389, BLDG.AP30 SE DECISION MADE: 27-JUL-00
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-6157
DEVICE: ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
ABBOTT LABORATORIES 510(k) NO: K002126(SPECIAL)
ATTN: JILL SACKETT PHONE NO : 847-937-4085
DEPT. 389, AP30 SE DECISION MADE: 20-JUL-00
200 ABBOTT PARK ROAD 510(k) STATEMENT
ABBOTT PARK, IL 60064-6157
DEVICE: ADVANCED UROSCIENCE INJECTION NEEDLE
ADVANCED UROSCIENCE INC. 510(k) NO: K002323(SPECIAL)
ATTN: KAREN E PETERSON PHONE NO : 651-653-8512
1290 HAMMOND RD. SE DECISION MADE: 31-JUL-00
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER SIZING BALLOON
AGA MEDICAL CORP. 510(k) NO: K993248(TRADITIONAL)
ATTN: JODI L LOCHER PHONE NO : 612-513-9227
682 MENDELSSOHN AVE. SE DECISION MADE: 12-JUL-00
GOLDEN VALLEY, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
ALCON UNIVERSAL, LTD. 510(k) NO: K001214(TRADITIONAL)
ATTN: MICHAEL E PFLEGER PHONE NO : 817-551-4877
6201 SOUTH FREEWAY SE DECISION MADE: 10-JUL-00
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DI
ALCON UNIVERSAL, LTD. 510(k) NO: K001235(TRADITIONAL)
ATTN: RALPH H LARSON PHONE NO : 817-551-4702
6201 SOUTH FREEWAY SE DECISION MADE: 03-JUL-00
FORT WORTH, TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994398(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-350-9798
11494 SORRENTO VALLEY RD., SE DECISION MADE: 27-JUL-00
SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: INSTANT-VIEW MORPHINE URINE CASSETTE TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994404(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-350-9798
11494 SORRENTO VALLEY RD., SE DECISION MADE: 05-JUL-00
SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K994409(TRADITIONAL)
ATTN: NAISHU WANG PHONE NO : 858-350-9798
11494 SORRENTO VALLEY RD., SE DECISION MADE: 10-JUL-00
SUITE F/M 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: MEDSCOPE
ALL-PRO IMAGING CORP. 510(k) NO: K001314(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-433-7676
70 CANTIAGUE ROCK RD. SE DECISION MADE: 25-JUL-00
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K001739(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 27-JUL-00
BUILDING WM 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN C
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K001924(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. SE DECISION MADE: 14-JUL-00
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPREMCAST "V"
AMERICAN DENT-ALL INC. 510(k) NO: K001383(TRADITIONAL)
ATTN: VACHAKAN H KHOIE PHONE NO : 818-662-0618
5140 SAN FERNANDO ROAD SE DECISION MADE: 05-JUL-00
GLENDALE, CA 91204 510(k) STATEMENT
DEVICE: AMT THERAPEUTIC TABLE, MODEL 748AMT
AMT MFG., INC. 510(k) NO: K001401(TRADITIONAL)
ATTN: BILL DEACON PHONE NO : 416 745 4739
510 ROWNTREE DAIRY RD. #5 SE DECISION MADE: 12-JUL-00
WOODBRIDGE, ON, CANADA L4L 8H2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ
ANDROMED, INC. 510(k) NO: K001306(TRADITIONAL)
ATTN: JEAN DUMAS PHONE NO : 514 336 0043
2310 BOUL ALFRED-NOBEL SE DECISION MADE: 20-JUL-00
ST.LAURENT, QUEBEC, CANADA H4S 2A4510(k) STATEMENT
DEVICE: ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
ANGIODYNAMICS, INC. 510(k) NO: K002101(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 31-JUL-00
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STY
ANSELL PERRY INC. 510(k) NO: K002192(SPECIAL)
ATTN: JAMES R CHATTERTON PHONE NO : 330-833-2811
1875 HARSH AVENUE, S.E. SE DECISION MADE: 27-JUL-00
MASSILLON, OH 44646-7199 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 19 GA PLASTIC REINFORCED EPIDURAL CATHETER
ARROW INTL., INC. 510(k) NO: K001587(SPECIAL)
ATTN: THOMAS D NICKEL PHONE NO : 610-478-3137
2400 BERNVILLE RD. SE DECISION MADE: 12-JUL-00
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE FLOW CONTROL UNIT
ARTHROCARE CORP. 510(k) NO: K001904(SPECIAL)
ATTN: BRUCE PROTHRO PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 17-JUL-00
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
ARTHROCARE CORP. 510(k) NO: K001936(SPECIAL)
ATTN: BETTY M JOHNSON PHONE NO : 408-736-0224
595 NORTH PASTORIA AVE. SE DECISION MADE: 19-JUL-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LA PERSONAL SCOOTER
ASSEMBLED PRODUCTS CORP. 510(k) NO: K000869(TRADITIONAL)
ATTN: GARY DARLING PHONE NO : 501-636-5776
115 EAST LINDEN SE DECISION MADE: 19-JUL-00
ROGERS, AR 72756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
ATL ULTRASOUND, INC. 510(k) NO: K002003(TRADITIONAL)
ATTN: TERRENCE J SWEENEY PHONE NO : 425-487-7602
P.O. BOX 3003 SE DECISION MADE: 13-JUL-00
BOTHELL, WA 98041-3003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM LITE MESH
ATRIUM MEDICAL CORP. 510(k) NO: K002093(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 24-JUL-00
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: DC TITAN
AUSTENAL, INC. 510(k) NO: K001798(TRADITIONAL)
ATTN: RONALD DUDEK PHONE NO : 773-735-0600
4101 WEST 51ST ST. SE DECISION MADE: 31-JUL-00
CHICAGO, IL 60632-4287 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001747(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 13-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001748(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 27-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001750(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 21-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001751(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 19-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001752(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 19-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001753(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 27-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
BARCO NV DISPLAY SYSTEMS 510(k) NO: K001754(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
8524 VILA LA JOLLA DRIVE SE DECISION MADE: 19-JUL-00
SUITE 161 510(k) SUMMARY AVAILABLE FROM FDA
LA JOLLA, CA 92037
DEVICE: RENU MULTIPLUS MULTI-PURPOSE SOLUTION
BAUSCH & LOMB, INC. 510(k) NO: K001539(TRADITIONAL)
ATTN: PAUL G STAPLETON PHONE NO : 716-338-8172
1400 NORTH GOODMAN ST. SE DECISION MADE: 31-JUL-00
ROCHESTER, NY 14603 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS
BAXTER HEALTHCARE CORP. 510(k) NO: K001063(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
17221 RED HILL AVENUE (IRVINE) SE DECISION MADE: 07-JUL-00
P.O. BOX 11150 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA,, CA 92711-1150
DEVICE: COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INF
BAXTER HEALTHCARE CORP. 510(k) NO: K002211(SPECIAL)
ATTN: JENNIFER M PAINE PHONE NO : 847-270-5825
RT. 120 AND WILSON ROAD SE DECISION MADE: 28-JUL-00
ROUND LAKE, IL 60073-0490 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSOMAT AND SPRAY SET
BAXTER HEALTHCARE CORP. 510(k) NO: K981089(TRADITIONAL)
ATTN: ANGELA BLACKSHERE PHONE NO : 818-507-5559
550 NORTH BRAND BOULEVARD SE DECISION MADE: 05-JUL-00
GLENDALE, CA 91023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATH
BECTON DICKINSON INFUSION THERAPY 510(k) NO: K002033(SPECIAL)
ATTN: LESLIE WOOD PHONE NO : 801-565-2504
9450 SOUTH STATE ST. SE DECISION MADE: 26-JUL-00
SANDY, UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR U
BEST MFG. CO. 510(k) NO: K001375(TRADITIONAL)
ATTN: DAVID C YOUNG PHONE NO : 706-862-2302
579 EDISON STREET SE DECISION MADE: 25-JUL-00
MENLO, GA 30731 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
BIO/DATA CORP. 510(k) NO: K001891(SPECIAL)
ATTN: RODNEY W SCARPELLI PHONE NO : 215-441-4000
155 GIBRALTAR ROAD SE DECISION MADE: 12-JUL-00
P.O. BOX 347 510(k) SUMMARY AVAILABLE FROM FDA
HORSHAM, PA 19044-0347
DEVICE: PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
BIOMET MANUFACTURING, INC. 510(k) NO: K001374(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 27-JUL-00
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAMARCO SPIDER PLATES
BIOMET, INC. 510(k) NO: K001271(TRADITIONAL)
ATTN: MARY VERSTYNEN PHONE NO : 219-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 14-JUL-00
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: PATIENT MATCHED TITANIUM ALLOY TROCHLEA
BIOMET, INC. 510(k) NO: K001350(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 26-JUL-00
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TI-MAX PROTRUSIO CAGE
BIOMET, INC. 510(k) NO: K001376(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 219-372-1761
P.O. BOX 587 SE DECISION MADE: 20-JUL-00
WARSAW, IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
BIOMET, INC. 510(k) NO: K002106(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 219-372-1761
AIRPORT INDUSTRIAL PARK SE DECISION MADE: 27-JUL-00
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
BIONX IMPLANTS, INC. 510(k) NO: K001378(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
HERMIANKATU 6-8 L SE DECISION MADE: 28-JUL-00
TAMPERE, FINLAND FIN-33720Y 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
BIOPLATE INC. 510(k) NO: K001530(TRADITIONAL)
ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-9500
6911 MELROSE AVENUE SE DECISION MADE: 21-JUL-00
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO TARA POLY INSERT
BIOPRO, INC. 510(k) NO: K990165(TRADITIONAL)
ATTN: CHERYL L WARSINSKE PHONE NO : 810-982-7777
17 SEVENTEENTH STREET SE DECISION MADE: 14-JUL-00
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL PAD
BIOSCAN, INC. 510(k) NO: K993684(TRADITIONAL)
ATTN: BUTCH SMITH PHONE NO : 505-897-2712
6 WALDEN ROAD SE DECISION MADE: 19-JUL-00
CORRALES, NM 87048 510(k) STATEMENT
DEVICE: BIOPACK
BIOSCAN, INC. 510(k) NO: K993685(TRADITIONAL)
ATTN: BUTCH SMITH PHONE NO : 505-897-2712
6 WALDEN ROAD SE DECISION MADE: 18-JUL-00
CORRALES, NM 87048 510(k) STATEMENT
DEVICE: LIGHT PATCH
BIOSCAN, INC. 510(k) NO: K993686(TRADITIONAL)
ATTN: BUTCH SMITH PHONE NO : 505-897-2712
6 WALDEN ROAD SE DECISION MADE: 18-JUL-00
CORRALES, NM 87048 510(k) STATEMENT
DEVICE: BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
BIOSENSE WEBSTER, INC. 510(k) NO: K001390(ABBREVIATED)
ATTN: MARIA D OCHOA PHONE NO : 800-729-9010
3333 DIAMOND CANYON RD. SE DECISION MADE: 21-JUL-00
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO E-SCAN
BIOSOUND ESAOTE, INC. 510(k) NO: K001894(SPECIAL)
ATTN: COLLEEN HITTLE PHONE NO : 317-849-1793
8000 CASTLEWAY DR. SE DECISION MADE: 06-JUL-00
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLAINE SCARCARE PATCH
BLAINE LABS, INC. 510(k) NO: K001608(TRADITIONAL)
ATTN: ROBERT BLAINE PHONE NO : 800-307-8818
9624 SOUTH JOHN STREET SE DECISION MADE: 25-JUL-00
UNIT 101 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: "BONUS" MECHANICAL WHEELCHAIR
BONUS ENT. CORP. 510(k) NO: K001391(TRADITIONAL)
ATTN: JEFF TEPERMEYSTER PHONE NO : 877-722-6687
228 LAKE MERCED HILL SE DECISION MADE: 24-JUL-00
SAN FRANCISCO, CA 94132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROVASIVE LITHOTRIPTOR FLEXPROBE II
BOSTON SCIENTIFIC CORP. 510(k) NO: K002084(SPECIAL)
ATTN: ROBERT J MICHALIK PHONE NO : 508-652-5801
ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 19-JUL-00
NATRICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFERX
BOWDENGS TECHNOLOGIES LLC 510(k) NO: K001596(TRADITIONAL)
ATTN: JEFFERY BOWDEN PHONE NO : 636-978-8846
54 ROCK CHURCH DRIVE SE DECISION MADE: 06-JUL-00
O'FALLON, MO 63366 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINSCAN
BRAINLAB AG 510(k) NO: K994413(TRADITIONAL)
ATTN: STEFAN VILSMEIER PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 13-JUL-00
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUORO-TEX CARDIOVASCULAR PATCH
BRIDGER BIOMED, INC. 510(k) NO: K994032(TRADITIONAL)
ATTN: BRUCE G RUEFER PHONE NO : 406-586-7666
2430 NORTH 7TH AVE., SUITE 4 SE DECISION MADE: 07-JUL-00
BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
CA GUARD, LTD. 510(k) NO: K992182(TRADITIONAL)
ATTN: FRANK M LEWIS PHONE NO : 901-682-0417
6258 SHADY GROVE ROAD E. SE DECISION MADE: 18-JUL-00
MEMPHIS, TN 38120 510(k) STATEMENT
DEVICE: CARDEON ASCENDING BALLOON CANNULA (ABC)
CARDEON CORP. 510(k) NO: K001371(TRADITIONAL)
ATTN: JANE BEGGS PHONE NO : 408-517-2522
10161 BUBB ROAD SE DECISION MADE: 07-JUL-00
CUPERTINO, CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMA DENTAL CHAIR AND UNIT
CASTELLINI S.P.A. 510(k) NO: K000837(TRADITIONAL)
ATTN: GIULIANO LANZARINI PHONE NO : 051 700 877
VIA SALICETO 22 SE DECISION MADE: 11-JUL-00
CASTEL MAGGIORE, BOLOGNA, ITALY 40510(k) STATEMENT
DEVICE: SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
CAVENDISH SCOTT INC. 510(k) NO: K001296(TRADITIONAL)
ATTN: PAUL TRESE PHONE NO : 303-792-7427
PRODUCTS DIVISION SE DECISION MADE: 17-JUL-00
7301 SOUTH PEORIA 510(k) SUMMARY AVAILABLE FROM FDA
ENGLEWOOD, CO 80111
DEVICE: CALCIJECT
CENTRIX INC. 510(k) NO: K001050(TRADITIONAL)
ATTN: SCOTT COHN PHONE NO : 203-929-5582
770 RIVER ROAD SE DECISION MADE: 21-JUL-00
SHELTON, CT 06484-5458 510(k) STATEMENT
DEVICE: THE V-BAG
CIRCULATORY TECHNOLOGY, INC. 510(k) NO: K001822(TRADITIONAL)
ATTN: YEHUDA TAMARI PHONE NO : 516-624-2424
21 SINGWORTH ST. SE DECISION MADE: 07-JUL-00
OYSTER BAY, NY 11771 510(k) STATEMENT
DEVICE: CRYSTAL-EEG MODEL 15
CLEVELAND MEDICAL DEVICES, INC. 510(k) NO: K001110(TRADITIONAL)
ATTN: ROBERT N SCHMIDT PHONE NO : 216-791-6720
11000 CEDAR AVE., SUITE 130 SE DECISION MADE: 05-JUL-00
CLEVELAND, OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANORET, MODEL 1000A
CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K001111(TRADITIONAL)
ATTN: ILAN SHARON PHONE NO : 972 485 00058
MATAM HIGH TECHNOLOGY CENTER SE DECISION MADE: 07-JUL-00
HAIFA, ISRAEL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
COGENT LIGHT TECHNOLOGIES, INC. 510(k) NO: K001698(TRADITIONAL)
ATTN: ED CURRIE PHONE NO : 800-294-2989
26145 TECHNOLOGY DR. SE DECISION MADE: 17-JUL-00
SANTA CLARITA, CA 91355-1137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
COHERENT STAR 510(k) NO: K001746(TRADITIONAL)
ATTN: ILIRIJA ENCINAS PHONE NO : 925-249-8031
1249 QUARRY LANE SE DECISION MADE: 19-JUL-00
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94566
DEVICE: CONTROL SOLUTIONS INC, MODEL CS3101
CONTROL SOLUTIONS, INC. 510(k) NO: K993420(TRADITIONAL)
ATTN: JOHN HAYDEN PHONE NO : 630-357-9008
508 W. 5TH AVE SE DECISION MADE: 19-JUL-00
NAPERVILLE, IL 60563 510(k) STATEMENT
DEVICE: PTA BALLOON CATHETER
COOK, INC. 510(k) NO: K001087(SPECIAL)
ATTN: KAREN BRADBURN PHONE NO : 800-468-1379
925 SOUTH CURRY PIKE SE DECISION MADE: 20-JUL-00
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402
DEVICE: CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
CORDIS CORP. 510(k) NO: K000062()
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDERHORN DRIVE SE DECISION MADE: 07-JUL-00
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F & 7F INTRODUCING CATHETERS (MODIFICATION)
CORDIS CORP. 510(k) NO: K001135(SPECIAL)
ATTN: DENNIS S GRIFFIN PHONE NO : 305-824-5283
14201 N.W. 60TH AVE. SE DECISION MADE: 03-JUL-00
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
CORDIS CORP. 510(k) NO: K001843(SPECIAL)
ATTN: ELENA JUGO PHONE NO : 305-824-2531
14201 N.W. 60TH AVE. SE DECISION MADE: 18-JUL-00
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA NETWORK AND CENTRAL
DATEX-OHMEDA, INC. 510(k) NO: K000647(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 978-640-0460
3 HIGHWOOD DR. SE DECISION MADE: 13-JUL-00
TEWKSBURY, MA 01876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIA
DEL MAR MEDICAL SYSTEMS, LLC. 510(k) NO: K001317(ABBREVIATED)
ATTN: ED CRESPIN PHONE NO : 949-250-3200
1621 ALTON PARKWAY SE DECISION MADE: 21-JUL-00
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STACKABLE CAGE SYSTEM
DEPUY ACROMED 510(k) NO: K001340(TRADITIONAL)
ATTN: KAREN JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 26-JUL-00
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z LINK CROSS CONNECTOR
DEPUY ACROMED 510(k) NO: K001372(TRADITIONAL)
ATTN: KAREN F JURCZAK PHONE NO : 508-828-3704
325 PARAMOUNT DR. SE DECISION MADE: 27-JUL-00
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROCOAT PRODIGY HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001778(SPECIAL)
ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944
700 ORTHOPAEDIC DR. SE DECISION MADE: 07-JUL-00
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-LOCK HIP STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K001982(SPECIAL)
ATTN: ARLENE C SAULL PHONE NO : 219-371-4904
700 ORTHOPAEDIC DR. SE DECISION MADE: 26-JUL-00
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
DIAMEDIX CORP. 510(k) NO: K001707(TRADITIONAL)
ATTN: LYNNE STIRLING PHONE NO : 305-324-2354
2140 NORTH MIAMI AVE. SE DECISION MADE: 07-JUL-00
MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATA MASTER PERFUSION MONITORING SYSTEM
DIDECO 510(k) NO: K001388(ABBREVIATED)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 28-JUL-00
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OMEGA 21 SYSTEM
EBI, L.P. 510(k) NO: K001357(TRADITIONAL)
ATTN: JONAS WILF PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 20-JUL-00
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI ANTERIOR CERVICAL PLATE SYSTEM
EBI, L.P. 510(k) NO: K001794(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 973-299-9022
100 INTERPACE PKWY. SE DECISION MADE: 12-JUL-00
PARSIPPANY, NJ 07054-1079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGITRON IEC II
ELLMAN INTL., INC. 510(k) NO: K001407(TRADITIONAL)
ATTN: FRANK LIN PHONE NO : 516-569-1482
1135 RAILROAD AVE., SE DECISION MADE: 24-JUL-00
ELLMAN BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
HEWLETT, NY 11557
DEVICE: STERICHEK TOTAL CHLORINE REAGENT STRIPS
ENVIRONMENTAL TEST SYSTEMS, INC. 510(k) NO: K001194(TRADITIONAL)
ATTN: DAVID A MORRIS PHONE NO : 219-262-2060
23575 COUNTY RD., #106 SE DECISION MADE: 11-JUL-00
ELKHART, IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
ERICH JAEGER GMBH 510(k) NO: K001502(SPECIAL)
ATTN: LARRY MURDOCK PHONE NO : 714-283-2228
22705 SAVI RANCH PARKWAY SE DECISION MADE: 12-JUL-00
YORBA LINDA, CA 92887-4645 510(k) STATEMENT
DEVICE: MODIFICATION TO PROMPT L-POP
ESPE DENTAL AG 510(k) NO: K001494(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 07-JUL-00
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONOVA NONABSORBABLE SUTURE, USP
ETHICON, INC. 510(k) NO: K001625(TRADITIONAL)
ATTN: PETER M CECCHINI PHONE NO : 908-218-2457
ROUTE 22 WEST SE DECISION MADE: 10-JUL-00
SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA V THERAPEUTIC ULTRASOUND
EXCEL TECH. LTD. 510(k) NO: K001166(TRADITIONAL)
ATTN: CAMERON MAHON PHONE NO : 905 829 5300
2568 BRISTOL CIRCLE SE DECISION MADE: 07-JUL-00
OAKVILLE, ONTARIO, CANADA L6H 5S1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED PATIENT EXAMINATION GLOVES, LATEX
FITCO DIPPED PRODUCTS PVT. LTD 510(k) NO: K001715(TRADITIONAL)
ATTN: JOSEPH J E PEREIRA PHONE NO : 914 844 21983
14-A COCHIN EXPORT PROCESSING SE DECISION MADE: 05-JUL-00
ZONE, KAKKANAND, KOCHI 510(k) STATEMENT
KERALA, INDIA 682 030
DEVICE: FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
FOTONA D.D. 510(k) NO: K001527(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 611 511215
STEGNE 7, SE DECISION MADE: 27-JUL-00
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-91
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K001873(TRADITIONAL)
ATTN: ARTHUR ELLINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVENUE SE DECISION MADE: 28-JUL-00
LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISANA DIGITAL TENS
FUJI DYNAMICS LIMITED 510(k) NO: K994265(TRADITIONAL)
ATTN: TORU HORIUCHI PHONE NO : 852 278 64218
UNIT 103, 23/F, LAWS PLAZA SE DECISION MADE: 06-JUL-00
788 CHEUNG SHA WAN RD. 510(k) STATEMENT
KOWLOON, HONG KONG
DEVICE: FDTENS 2010
FUJI DYNAMICS LIMITED 510(k) NO: K994266(TRADITIONAL)
ATTN: TORU HORIUCHI PHONE NO : 852 278 64218
UNIT 103, 23/F, LAWS PLAZA SE DECISION MADE: 06-JUL-00
788 CHEUNG SHA WAN RD. 510(k) STATEMENT
KOWLOON, HONG KONG
DEVICE: PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMOD
GAMBRO RENAL PRODUCTS 510(k) NO: K001156(ABBREVIATED)
ATTN: BENITA BRADFORD PHONE NO : 303-231-4637
10810 W. COLLINS AVE. SE DECISION MADE: 07-JUL-00
LAKEWOOD, CO 80215 510(k) STATEMENT
DEVICE: GRADIA
GC AMERICA, INC. 510(k) NO: K001518(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH STREET SE DECISION MADE: 05-JUL-00
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GC FUJICEM
GC AMERICA, INC. 510(k) NO: K001730(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH STREET SE DECISION MADE: 17-JUL-00
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K001268(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 17-JUL-00
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DASH 3000/4000 PATIENT MONITOR
GE MARQUETTE MEDICAL SYSTEMS, INC.510(k) NO: K001359(TRADITIONAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-2090
8200 WEST TOWER AVE. SE DECISION MADE: 18-JUL-00
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARDY DISK CLARITHROMYCIN, 15MCG
HARDY DIAGNOSTICS 510(k) NO: K001728(TRADITIONAL)
ATTN: MELISSA TRAYLOR PHONE NO : 805-346-2766
1430 WEST MCCOY LANE SE DECISION MADE: 27-JUL-00
SANTA MARIA, CA 93455 510(k) STATEMENT
DEVICE: POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABE
HARTALEGA SDN BHD 510(k) NO: K001959(TRADITIONAL)
ATTN: NURU AISYAH KONG PHONE NO : 603 634 2177
9 JALAN KUANG BULAN TAMAN SE DECISION MADE: 26-JUL-00
KEPONG INDUSTRIAL ESTATE 510(k) STATEMENT
KUALA LUMPUR, MALAYSIA 52100
DEVICE: ISOLETTE INFANT INCUBATOR, MODEL C2HS
HILL-ROM AIR-SHIELDS 510(k) NO: K001242(TRADITIONAL)
ATTN: JAMES G CARPENTER PHONE NO : 215-675-5200
330 JACKSONVILLE RD. SE DECISION MADE: 13-JUL-00
HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HITACHI AIRIS II
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K001334(TRADITIONAL)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 06-JUL-00
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001385(TRADITIONAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283
359 VETERANS BLVD. SE DECISION MADE: 27-JUL-00
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR SHOULDER OFFSET HUMERAL HEAD
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001419(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187
59 ROUTE 17 SE DECISION MADE: 27-JUL-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CENTAUR SPINAL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001844(SPECIAL)
ATTN: MARY-CATHERINE DILLON PHONE NO : 201-760-8117
59 ROUTE 17 SE DECISION MADE: 19-JUL-00
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX FIXATION PINS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001886(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283
359 VETERANS BLVD. SE DECISION MADE: 12-JUL-00
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K001957(SPECIAL)
ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283
359 VETERANS BLVD. SE DECISION MADE: 25-JUL-00
RUTHERFORD, NJ 07070-2584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTERNAL FIXATION ANCHOR PIN
IMMEDICA, INC. 510(k) NO: K001228(TRADITIONAL)
ATTN: ROY BOGERT PHONE NO : 973-635-9040
100 PASSAIC AVE. SE DECISION MADE: 07-JUL-00
CHATHAM, NJ 07928-2848 510(k) STATEMENT
DEVICE: GENERIC BLOOD GLUCOSE TEST STRIP
INBIOS INTL., INC. 510(k) NO: K001092(TRADITIONAL)
ATTN: ESTELA I RAYCHAUDHURI PHONE NO : 206-344-5821
562 1ST. AVE. SOUTH, SUITE 600 SE DECISION MADE: 26-JUL-00
SEATTLE, WA 98104 510(k) STATEMENT
DEVICE: CARDIOVISE ECG INTERPRETATIVE SOFTWARE
INOVISE MEDICAL, INC 510(k) NO: K001349(TRADITIONAL)
ATTN: DEBRA A OLSON PHONE NO : 503-554-4227
1025 INDUSTRIAL PARKWAY SE DECISION MADE: 27-JUL-00
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
NEWBERG, OR 97132
DEVICE: FOCUS
INSTRUMENTARIUM CORP. 510(k) NO: K001729(TRADITIONAL)
ATTN: DOUG WOODS PHONE NO : 414-747-1030
300 WEST EDGERTON AVENUE SE DECISION MADE: 13-JUL-00
MILWAUKEE, WI 53207 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL EN
INTUITIVE SURGICAL, INC. 510(k) NO: K990144(TRADITIONAL)
ATTN: MICHAEL DANIEL PHONE NO : 650-237-7036
1340 W. MIDDLEFIELD ROAD SE DECISION MADE: 11-JUL-00
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
INVACARE CORP. 510(k) NO: K001777(TRADITIONAL)
ATTN: EDWARD A KROLL PHONE NO : 440-329-6595
ONE INVACARE WAY SE DECISION MADE: 24-JUL-00
ELYRIA, OH 44036-2125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
IONICS MEDICAL CORP. 510(k) NO: K983667(TRADITIONAL)
ATTN: M. LAINE MASHBURN PHONE NO : 800-444-0624
702 13TH ST., #108 SE DECISION MADE: 05-JUL-00
MIAMI BEACH, FL 33139 510(k) STATEMENT
DEVICE: ISLAND BIOSURGICAL BNS KIT #3
ISLAND BIOSURGICAL, LLC. 510(k) NO: K001583(TRADITIONAL)
ATTN: HUNTER A MCKAY PHONE NO : 800-858-5359
18 MEADOW LN. SE DECISION MADE: 13-JUL-00
MERCER ISLAND, WA 98040-5340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D; PROJECT DW269#25
IVOCLAR NORTH AMERICA, INC. 510(k) NO: K001469(TRADITIONAL)
ATTN: PETER P MANCUSO PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 05-JUL-00
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: CORRECT PLUS
JENERIC/PENTRON, INC. 510(k) NO: K001218(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NORTH PLAINS INDUSTRIAL RD. SE DECISION MADE: 05-JUL-00
P.O. BOX 724 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492-0724
DEVICE: SCULPTURE FLOW
JENERIC/PENTRON, INC. 510(k) NO: K001623(TRADITIONAL)
ATTN: ANNMARIE TENERO PHONE NO : 203-265-7397
53 NO.PLAINS INDUSTRIAL RD SE DECISION MADE: 11-JUL-00
WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JILCO TRACTION-FLEXION CHAIR
JILCO ENT. 510(k) NO: K001361(TRADITIONAL)
ATTN: DAVID K LEONARD PHONE NO : 816-965-9381
11913 ARMITAGE DR. SE DECISION MADE: 19-JUL-00
GRANDVIEW, MO 64030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
JOHNSON & JOHNSON MEDICAL, INC. 510(k) NO: K001690(TRADITIONAL)
ATTN: DORENE MARKWIESE PHONE NO : 817-262-4450
2500 ARBROOK BLVD SE DECISION MADE: 31-JUL-00
P.O. BOX 90130 510(k) SUMMARY AVAILABLE FROM FDA
ARLINGTON, TX 76004-3130
DEVICE: SMILIE PC
JULIE ALLIANCE 510(k) NO: K001445(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 904-672-0450
110 EAST GRANADA BOULEVARD SE DECISION MADE: 26-JUL-00
SUITE 208 P.O. BOX 36 510(k) STATEMENT
ORMOND BEACH, FL 32175-0036
DEVICE: KSEA BIPOLAR COAGULATING ELECTRODES
KARL STORZ ENDOSCOPY 510(k) NO: K001630(TRADITIONAL)
ATTN: KEVIN KENNAN PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 19-JUL-00
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ 3D VIDEO SYSTEM
KARL STORZ IMAGING, INC. 510(k) NO: K001362(TRADITIONAL)
ATTN: TERRY FERNANDEZ PHONE NO : 805-968-5563
175 CREMONA DR. SE DECISION MADE: 17-JUL-00
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
KAWASUMI LABORATORIES AMERICA, INC510(k) NO: K001423(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-630-5554
5905 C HAMPTON OAKS PKWY. SE DECISION MADE: 21-JUL-00
TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
KAWASUMI LABORATORIES AMERICA, INC510(k) NO: K001424(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-630-5554
5905 C HAMPTON OAKS PKWY. SE DECISION MADE: 21-JUL-00
TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
KAWASUMI LABORATORIES AMERICA, INC510(k) NO: K001426(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-630-5554
5905 C HAMPTON OAKS PKWY. SE DECISION MADE: 21-JUL-00
TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM KNEE SYSTEM
KINAMED, INC. 510(k) NO: K994214(TRADITIONAL)
ATTN: JOEL SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DRIVE SE DECISION MADE: 19-JUL-00
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-5
KLS-MARTIN L.P. 510(k) NO: K000580(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 24-JUL-00
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROLONG, MODELS PL50, PL100, PL150
LIFE-TECH INTL., INC. 510(k) NO: K001129(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600
4235 GREENBRIAR DR. SE DECISION MADE: 06-JUL-00
STAFFORD, TX 77477-3995 510(k) STATEMENT
DEVICE: RESOLUTION CHOLESTEROL MONITOR
LIFESTREAM TECHNOLOGIES, INC. 510(k) NO: K000610(TRADITIONAL)
ATTN: JACK CONNOLLY PHONE NO : 208-457-9409
51O CLEARWATER LOOP, SUITE 101 SE DECISION MADE: 21-JUL-00
POST FALLS, ID 83854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
LOBOB LABORATORIES, INC. 510(k) NO: K001964(SPECIAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1040
2000 M STREET (#700) SE DECISION MADE: 18-JUL-00
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUNAR REPORT GENERATOR II
LUNAR CORP. 510(k) NO: K001756(TRADITIONAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 06-JUL-00
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC REFERENCE DATA
LUNAR CORP. 510(k) NO: K001812(TRADITIONAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 10-JUL-00
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MACROSORBOS PROTECTIVE SHEET
MACROPORE, INC. 510(k) NO: K994158(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 24-JUL-00
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLINCKRODT, GOODKNIGHT 418S
MALLINCKRODT DEVELOPPMENT FRANCE 510(k) NO: K001845(SPECIAL)
ATTN: MOUSTAFA ANKI PHONE NO : 333 834 48500
10 ALLEE PELLETIER DOISY SE DECISION MADE: 05-JUL-00
VILLERS-LES-NANCY, FRANCE 54601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETCAM II
MASSIE RESEARCH LABORATORIES, INC.510(k) NO: K001275(TRADITIONAL)
ATTN: BERT MASSIE PHONE NO : 925-560-2465
6761 SIERRA CT., SUITE E SE DECISION MADE: 13-JUL-00
DUBLIN, CA 94568 510(k) STATEMENT
DEVICE: GASTRIC LAVAGE VALVE
MED-VAC CORP. 510(k) NO: K990365(TRADITIONAL)
ATTN: LANIS P PFOLSGROF PHONE NO : 414-639-1740
24 LAKEWOOD DRIVE SE DECISION MADE: 26-JUL-00
RACINE, WI 53402 510(k) STATEMENT
DEVICE: MEDI-CULT UNIVERSAL IVF-MEDIUM
MEDI-CULT A/S 510(k) NO: K991279(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 20-JUL-00
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AN
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K001758(TRADITIONAL)
ATTN: SCOT D KINGHORN PHONE NO : 805-987-7891
5300 ADOLFO ROAD SE DECISION MADE: 05-JUL-00
CAMARILLO, CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEEDLELESS TRANSFER DEVICE
MEDIMOP MEDICAL PROJECTS, LTD. 510(k) NO: K001831(TRADITIONAL)
ATTN: BRUCE F MACKLER PHONE NO : 202-263-8900
815 CONNECTION AVENUE, N.W. SE DECISION MADE: 11-JUL-00
WASHINGTON, DC 20006-4004 510(k) STATEMENT
DEVICE: POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEI
MEDIPURE CORPORATION (M) SDN. BHD.510(k) NO: K001165(TRADITIONAL)
ATTN: LEE SON HONG PHONE NO : 605 776 5103
NO: 14, JALAN TAIPING SE DECISION MADE: 05-JUL-00
KUALA KANGSAR, PERAK, MALAYSIA 330510(k) STATEMENT
DEVICE: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WI
MEDTRONIC AVE, INC. 510(k) NO: K994141(TRADITIONAL)
ATTN: SHELLY TRIMM PHONE NO : 707-566-1443
3576 UNOCAL PL. SE DECISION MADE: 21-JUL-00
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K001255(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 11-JUL-00
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX HBA1C
METRIKA, INC. 510(k) NO: K000887(TRADITIONAL)
ATTN: JOEAL M BLATT PHONE NO : 408-524-2255
510 OAKMEAD PARKWAY SE DECISION MADE: 26-JUL-00
SUNNYVALE, CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSONIC PLUS, MODEL AP-100
METRON MEDICAL AUSTRALIA P/L 510(k) NO: K001370(TRADITIONAL)
ATTN: ROB HOPKINS PHONE NO : 61 397 751234
57 ASTER AVE. SE DECISION MADE: 17-JUL-00
CARRUM DOWNS, VICTORIA, AUSTRALIA 510(k) STATEMENT
DEVICE: REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, S
MICRO THERAPEUTICS, INC. 510(k) NO: K001966(SPECIAL)
ATTN: MARIBELLE AGUINALDO PHONE NO : 949-837-3700
2 GOODYEAR SE DECISION MADE: 20-JUL-00
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND
MOLNLYCKE HEALTH CARE INC 510(k) NO: K000901(TRADITIONAL)
ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383
500 BALDWIN TOWER SE DECISION MADE: 05-JUL-00
EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLINIDRAPE REINFORCED SURGICAL GOWNS
MOLNLYCKE HEALTH CARE INC 510(k) NO: K000902(TRADITIONAL)
ATTN: MIGUEL A NEGRON PHONE NO : 610-499-3383
500 BALDWIN TOWER SE DECISION MADE: 11-JUL-00
EDDYSTONE, PA 19022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSIDE VIEW
MONADNOCK OPTICS, INC. 510(k) NO: K001217(TRADITIONAL)
ATTN: LEONARD J BONNELL PHONE NO : 215-938-1499
1464 HOLCOMB ROAD SE DECISION MADE: 11-JUL-00
HUNTINGDON VALLEY, PA 19006 510(k) STATEMENT
DEVICE: MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
MULTISAFE SDN BHD 510(k) NO: K001497(TRADITIONAL)
ATTN: ABD. HADI BIN HUSIN PHONE NO : 605 434 8269
LOT 764 SE DECISION MADE: 26-JUL-00
BIDOR INDUSTRIAL ESTATE 510(k) STATEMENT
BIDOR, PERAK, MALAYSIA 35500
DEVICE: MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
MULTISAFE SDN BHD 510(k) NO: K001619(TRADITIONAL)
ATTN: ABD. HADI BIN HUSIN PHONE NO : 605 434 8269
LOT 764 SE DECISION MADE: 26-JUL-00
BIDOR INDUSTRIAL ESTATE 510(k) STATEMENT
35500 BIDOR, PERAK, MALAYSIA 35500
DEVICE: NANMA VACUUM PUMP
NANMA MFG CO., LTD. 510(k) NO: K993909(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 19-JUL-00
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: IM-9C MICROINJECTORS
NARISHIGE CO., LTD. 510(k) NO: K001910(TRADITIONAL)
ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383
29-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 07-JUL-00
SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM-9A MICROINJECTORS
NARISHIGE CO., LTD. 510(k) NO: K001911(TRADITIONAL)
ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383
29-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 07-JUL-00
SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IM-9B MICROINJECTORS
NARISHIGE CO., LTD. 510(k) NO: K001912(TRADITIONAL)
ATTN: MITSUKO YONEYAMA PHONE NO : 81 333 088383
29-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 07-JUL-00
SETAGAYA-KU, TOKYO, JAPAN 157-0062510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYN
NEURO SCAN LABS 510(k) NO: K001324(TRADITIONAL)
ATTN: DAVID B JONES PHONE NO : 915-845-5600
5700 CROMO DR., SUITE 100 SE DECISION MADE: 11-JUL-00
EL PASO, TX 79912-5538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE KALIX IMPLANT
NEWDEAL S.A. 510(k) NO: K001231(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 11-JUL-00
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPI-STAR SURGICAL LASER SYSTER
NIDEK, INC. 510(k) NO: K990119(TRADITIONAL)
ATTN: JERRY TSUTSUMI PHONE NO : 510-226-5700
47651 WESTINGHOUSE DR. SE DECISION MADE: 27-JUL-00
FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNIPER, MODEL OR-3872XX SERIES
NIPRO MEDICAL CORP. 510(k) NO: K001251(TRADITIONAL)
ATTN: JACK FRAUTSCHI PHONE NO : 903-675-9321
1445 FLAT GREEK ROAD SE DECISION MADE: 07-JUL-00
ATHENS, TX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIEVENTS, VERSION 4.2
NON-INVASIVE MONITORING SYSTEMS, I510(k) NO: K001369(TRADITIONAL)
ATTN: MARVIN A SACKNER, M.D. PHONE NO : 305-534-3694
1840 WEST AVE. SE DECISION MADE: 26-JUL-00
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
NONIN MEDICAL, INC. 510(k) NO: K001930(SPECIAL)
ATTN: RICHARD P BENNETT PHONE NO : 612-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 20-JUL-00
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR180-II
NORTHEAST MONITORING, INC. 510(k) NO: K001288(ABBREVIATED)
ATTN: RODNEY L CAMBRE PHONE NO : 978-440-8438
730 BOSTON POST ROAD SE DECISION MADE: 20-JUL-00
SUITE 23 510(k) SUMMARY AVAILABLE FROM FDA
SUDBURY, MA 01776
DEVICE: INTRODUCER SHEATH
NOVASYS MEDICAL, INC. 510(k) NO: K001328(TRADITIONAL)
ATTN: THOMAS C WEHMAN PHONE NO : 408-730-6300
687 NO. PASTORIA AVENUE SE DECISION MADE: 17-JUL-00
SUNNYVALE, CA 94086 510(k) STATEMENT
DEVICE: NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
NUMED, INC. 510(k) NO: K001804(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 12-JUL-00
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
NUVASIVE, INC. 510(k) NO: K001323(TRADITIONAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-271-7070
10065 OLD GROVE RD. SE DECISION MADE: 25-JUL-00
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
OMRON HEALTHCARE, INC. 510(k) NO: K001848(SPECIAL)
ATTN: OSAMU SHIRASAKI PHONE NO : 847-680-6200
300 LAKEVIEW PKWY. SE DECISION MADE: 03-JUL-00
VERNON HILLS, IL 60061 510(k) STATEMENT
DEVICE: PROTON BEAM THERAPY SYSTEM (PBTS)
OPTIVUS TECHNOLOGY, INC. 510(k) NO: K992414(TRADITIONAL)
ATTN: RENEE J THIBEAULT PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 21-JUL-00
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY P
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K001885(SPECIAL)
ATTN: MARLENE SHULMAN PHONE NO : 716-453-4041
100 INDIGO CREEK DRIVE SE DECISION MADE: 20-JUL-00
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPI BAND
ORTHOMERICA PRODUCTS, INC. 510(k) NO: K001167(TRADITIONAL)
ATTN: WILLIAM H.E. VON OEHSEN PHONE NO : 202-624-7249
1001 PENNSYLVANIA AVE. NW. SE DECISION MADE: 07-JUL-00
6TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K001032(TRADITIONAL)
ATTN: JAMES W HARRIS PHONE NO : 301-527-4719
2440 RESEARCH BLVD SE DECISION MADE: 24-JUL-00
ROCKVILLE, MD 20850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)
OTTO BOCK ORTHOPAEDISCHE INDUSTRIE510(k) NO: K001890(TRADITIONAL)
ATTN: E. P. BERT HARMAN PHONE NO : 612-553-9464
3000 XENIUM LANE NORTH SE DECISION MADE: 24-JUL-00
MINNEAPOLIS, MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOOP ELECTRODE, BALL ELECTRODE
PALM MEDICAL USA, INC. 510(k) NO: K993527(TRADITIONAL)
ATTN: MARK J KAHN PHONE NO : 325-376-0380
6322 N.W. 18TH DR., SUITE 170 SE DECISION MADE: 06-JUL-00
GAINESVILLE, FL 32653 510(k) STATEMENT
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K001516(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 303-423-9504
12750 WEST 42ND AVE. SE DECISION MADE: 12-JUL-00
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K001612(TRADITIONAL)
ATTN: LINDA K DILLON PHONE NO : 800-321-9813
12750 WEST 42ND AVE. SE DECISION MADE: 18-JUL-00
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSET SENSOR, MODEL 2000
PELVICARE, INC. 510(k) NO: K001386(TRADITIONAL)
ATTN: WALTER D WALLACH PHONE NO : 949-365-5701
28202 CABOT RD., SUITE 300 SE DECISION MADE: 17-JUL-00
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REDON SET
PFM PRODUKTE FUR DIE MEDIZIN AG 510(k) NO: K001716(TRADITIONAL)
ATTN: SALVADORE F PALOMARES PHONE NO : 949-463-6146
154 VIA LAMPARA SE DECISION MADE: 19-JUL-00
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SL-PLUS AND SLR-PLUS STEMS
PLUS ORTHOPEDICS 510(k) NO: K001942(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 858-455-2400
3550 GENERAL ATOMICS CT. SE DECISION MADE: 25-JUL-00
BLDG. 15-100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121-1122
DEVICE: BIOSCANNER TRIGLYCERIDES TEST STRIPS
POLYMER TECHNOLOGY SYSTEMS, INC. 510(k) NO: K000586(TRADITIONAL)
ATTN: MARGO ENRIGHT PHONE NO : 317-870-5610
7736 ZIONSVILLE RD. SE DECISION MADE: 03-JUL-00
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
PROCERA SANDVIK, INC. 510(k) NO: K001418(TRADITIONAL)
ATTN: MARTIN STERNER PHONE NO : 201-398-7412
1872 MCBRIDE AVE. SE DECISION MADE: 05-JUL-00
FAIR LAWN, NJ 07410-2812 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSATION -VACUUM ASSIST DEVICES
PROSURG, INC. 510(k) NO: K000124(TRADITIONAL)
ATTN: LEE BUI PHONE NO : 408-945-4044
2193 TRADE ZONE BLVD. SE DECISION MADE: 10-JUL-00
SAN JOSE, CA 95131 510(k) STATEMENT
DEVICE: POCKET ULTRASONIC PACHYMETER
QUANTEL MEDICAL 510(k) NO: K993674(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 13-JUL-00
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT STIM
R & D MEDICAL PRODUCTS, INC. 510(k) NO: K001117(TRADITIONAL)
ATTN: JAMES TRAN PHONE NO : 562-274-0361
20492 CRESCENT BAY DR. #106 SE DECISION MADE: 05-JUL-00
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIZA BAND STRETCHER (RBS)-60000
R-MED, INC. 510(k) NO: K001236(TRADITIONAL)
ATTN: EROL D RIZA PHONE NO : 419-693-7481
3465 NAVARRE AVE., BOX 167636 SE DECISION MADE: 17-JUL-00
OREGON, OH 43616-7636 510(k) STATEMENT
DEVICE: OPTICAL TRACKING SYSTEM (OTS)
RADIONICS, INC. 510(k) NO: K001950(SPECIAL)
ATTN: KEVIN J O'CONNELL PHONE NO : 781-272-1233
22 TERRY AVE. SE DECISION MADE: 26-JUL-00
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTCUP PRO-5, MODEL 1986678
ROCHE DIAGNOSTICS CORP. 510(k) NO: K001356(SPECIAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742
9115 HAGUE ROAD SE DECISION MADE: 10-JUL-00
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONTRAK TESTCUP 501, MODEL 3016633
ROCHE DIAGNOSTICS CORP. 510(k) NO: K001421(SPECIAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-576-3742
9115 HAGUE RD. SE DECISION MADE: 12-JUL-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS INSULIN CALSET
ROCHE DIAGNOSTICS CORP. 510(k) NO: K001906(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-576-3544
9115 HAGUE RD. SE DECISION MADE: 13-JUL-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K993706(TRADITIONAL)
ATTN: PRISCILLA A HAMILL PHONE NO : 317-576-3723
9115 HAGUE RD. SE DECISION MADE: 24-JUL-00
INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL
ROCHESTER MEDICAL CORP. 510(k) NO: K001143(TRADITIONAL)
ATTN: MARY WILEN PHONE NO : 507-533-9612
ONE ROCHESTER MEDICAL DR. SE DECISION MADE: 07-JUL-00
STEWARTVILLE, MN 55976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
ROLL-ABILITY (PTY) LTD. 510(k) NO: K001298(TRADITIONAL)
ATTN: KEITH F MYBURGH PHONE NO : 540-776-0363
6162 STEEPLECHASE DRIVE SE DECISION MADE: 18-JUL-00
ROANOKE, VA 24018 510(k) STATEMENT
DEVICE: LIGHT-CURED ORTHODONTIC BAND CEMENT
SCIENTIFIC PHARMACEUTICALS, INC. 510(k) NO: K001446(TRADITIONAL)
ATTN: JAN A ORLOWSKI PHONE NO : 909-595-9922
3221 PRODUCER WAY SE DECISION MADE: 21-JUL-00
POMONA, CA 91768 510(k) STATEMENT
DEVICE: COOL-TEC ELECTRODES
SEEDLING ENTERPRISES. LLC 510(k) NO: K001723(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVE. SE DECISION MADE: 19-JUL-00
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVERNESS MEDICAL EARLY PREGNANCY TEST
SELFCARE, INC. 510(k) NO: K002049(SPECIAL)
ATTN: CAROL A ADILETTO PHONE NO : 781-647-3900
200 PROSPECT ST. SE DECISION MADE: 27-JUL-00
WALTHAM, MA 02154-3457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLO
SGMP CO., LTD. 510(k) NO: K002175(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 31-JUL-00
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOV
SGMP CO., LTD. 510(k) NO: K002176(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 31-JUL-00
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
SHANGHAI PM PLASTICS ENT. CO., LTD510(k) NO: K001432(TRADITIONAL)
ATTN: CHANG T SUN PHONE NO : 011 862 157814212
NO. 258, YUSHU RD. CHANGQIAO SE DECISION MADE: 05-JUL-00
TOWNSHIP, SHOHJIANG COUNTY, SH, CH510(k) STATEMENT
DEVICE: NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
SHANGHAI POSEIDON PLASTIC PRODUCTS510(k) NO: K001836(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 26-JUL-00
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
SHANGHAI POSEIDON PLASTIC PRODUCTS510(k) NO: K001837(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 862 162 095147
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 11-JUL-00
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG HONGXIANG PLASTICS PR510(k) NO: K001863(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 909-262-8860
12390 EAST END AVENUE SE DECISION MADE: 11-JUL-00
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ LDL CHOLESTEROL TEST SYSTEM
SIGMA DIAGNOSTICS, INC. 510(k) NO: K993741(TRADITIONAL)
ATTN: WILLIAM R GILBERT PHONE NO : 314-286-7880
545 SOUTH EWING AVE. SE DECISION MADE: 03-JUL-00
ST. LOUIS, MO 63103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
SIMS BCI, INC. 510(k) NO: K001770(SPECIAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 05-JUL-00
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPAP SYSTEM, MODEL 102001
SIMS PORTEX, INC. 510(k) NO: K001318(TRADITIONAL)
ATTN: BRIAN D FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 20-JUL-00
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
SMITH & NEPHEW ENT. 510(k) NO: K001902(TRADITIONAL)
ATTN: ALICIA FARAGE PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 10-JUL-00
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOCOM SILICONE SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K001466(TRADITIONAL)
ATTN: ALICIA E FARAGE PHONE NO : 901-373-0279
2925 APPLING ROAD SE DECISION MADE: 26-JUL-00
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PROVIDENT HIP SYSTEM
STELKAST CO. 510(k) NO: K001745(SPECIAL)
ATTN: DONALD A STEVENS PHONE NO : 412-322-8280
800 VINIAL ST. #210 SE DECISION MADE: 27-JUL-00
PITTSBURGH, PA 15212 510(k) STATEMENT
DEVICE: SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
SULZER ORTHOPEDICS, INC. 510(k) NO: K001320(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 512-432-9306
9900 SPECTRUM DR. SE DECISION MADE: 07-JUL-00
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
SULZER ORTHOPEDICS, INC. 510(k) NO: K001536(TRADITIONAL)
ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202
9900 SPECTRUM DR. SE DECISION MADE: 27-JUL-00
AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOINSULATED SILICONE PUNCTUM PLUG
SURGIDEV CORP. 510(k) NO: K001234(TRADITIONAL)
ATTN: MARGARET ALDRED PHONE NO : 805-683-3851
5743 THORNWOOD DR. SE DECISION MADE: 11-JUL-00
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGILIGHT, INC EXCIMER LASER
SURGILIGHT, INC. 510(k) NO: K993328(TRADITIONAL)
ATTN: TIMOTHY J SHEA PHONE NO : 407-482-4555
12001 SCIENCE DR., SE DECISION MADE: 18-JUL-00
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAKE 1 BITE
SYBRON DENTAL SPECIALTIES INC. 510(k) NO: K001876(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVENUE SE DECISION MADE: 21-JUL-00
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMASEED, MODEL BT-103-3
SYNCOR PHARMACEUTICALS, INC. 510(k) NO: K994016(TRADITIONAL)
ATTN: GARY GILMORE PHONE NO : 303-279-1914
1313 WASHINGTON AVE. SE DECISION MADE: 14-JUL-00
GOLDEN, CO 80401 510(k) STATEMENT
DEVICE: PHARMASEED, MODEL BT-125-3
SYNCOR PHARMACEUTICALS, INC. 510(k) NO: K994018(TRADITIONAL)
ATTN: GARY GILMORE PHONE NO : 303-279-1914
1313 WASHINGTON AVE. SE DECISION MADE: 17-JUL-00
GOLDEN, CO 80401 510(k) STATEMENT
DEVICE: MEDICAL IMAGE MERGE (MIM)
SYNTERMED, INC. 510(k) NO: K001276(TRADITIONAL)
ATTN: KENNETH F VAN TRAIN PHONE NO : 714-281-1256
210 INTERSTATE NORTH PARKWAY SE DECISION MADE: 17-JUL-00
SUITE 700 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30339
DEVICE: SYNTHES BIORESORBABLE SUTURE ANCHOR
SYNTHES (USA) 510(k) NO: K994161(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 28-JUL-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: SYNTHES CERVIFIX SYSTEM
SYNTHES SPINE 510(k) NO: K001864(SPECIAL)
ATTN: JONATHAN GILBERT PHONE NO : 610-647-9700
P.O. BOX 0548 SE DECISION MADE: 20-JUL-00
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301
DEVICE: LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
TARACAN PTY. LTD. 510(k) NO: K001772(SPECIAL)
ATTN: KEITH DEGENHARDT PHONE NO : 08 822 36644
258 HALIFAX STREET SE DECISION MADE: 06-JUL-00
ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) STATEMENT
DEVICE: DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
THE DANIELS CORPORATION 510(k) NO: K001337(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 05-JUL-00
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS
THE PROMETHEUS GROUP 510(k) NO: K001515(TRADITIONAL)
ATTN: RICHARD HORTON PHONE NO : 781-582-2328
2 MALLARDS COVE SE DECISION MADE: 31-JUL-00
DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAGE THERMACOOL SYSTEM
THERMAGE, INC. 510(k) NO: K000944(TRADITIONAL)
ATTN: KEITH MULLOWNEY PHONE NO : 510-782-2286
4058 POINT EDEN WAY SE DECISION MADE: 19-JUL-00
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
THERMOQUEST CORP. 510(k) NO: K001524(TRADITIONAL)
ATTN: RICHARD L MILLER PHONE NO : 740-373-4763
MILL CREEK ROAD SE DECISION MADE: 12-JUL-00
MARIETTA, OH 45750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIF
TISSUE TECHNOLOGIES, INC. 510(k) NO: K002071(TRADITIONAL)
ATTN: JESSE KRAMER PHONE NO : 415-885-6269
1370 GREEN STREET SE DECISION MADE: 24-JUL-00
SAN FRANCISO, CA 94109 510(k) STATEMENT
DEVICE: TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
TOP QUALITY MFG. INC. 510(k) NO: K000050(TRADITIONAL)
ATTN: ART WARD PHONE NO : 813-645-2855
3234 ELLA LANE SE DECISION MADE: 27-JUL-00
NEW PORT RICHEY, FL 34655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNIER CEMENT RESTRICTOR
TORNIER S.A. 510(k) NO: K001932(SPECIAL)
ATTN: DAVID W SCHLERF PHONE NO : 925-356-2640
200 GREGORY LANE SE DECISION MADE: 20-JUL-00
SUITE C-100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANT HILL, CA 94523-3389
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFO
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K001558(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 24-JUL-00
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K001573(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 440-250-1665
29299 CLEMENS RD. SUITE 1-K SE DECISION MADE: 18-JUL-00
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: AEROTRACH PLUS VALVED HOLDING CHAMBER ("VHC")
TRUDELL MEDICAL INT'L 510(k) NO: K001137(SPECIAL)
ATTN: TOM HOLBROOK PHONE NO : 519 455 7060
725 THIRD STREET SE DECISION MADE: 05-JUL-00
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: BOOKER BOX, MODEL PAD 5010
TZ MEDICAL, INC. 510(k) NO: K993205(TRADITIONAL)
ATTN: BYRON KAHLER PHONE NO : 503-639-7221
15858 S.W. UPPER BOONES FERRY SE DECISION MADE: 20-JUL-00
RD. 510(k) STATEMENT
LAKE OSWEGO, OR 97035
DEVICE: AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
UNITED STATES SURGICAL CORP. 510(k) NO: K001450(TRADITIONAL)
ATTN: CHRISTOPHER A GRAHAM PHONE NO : 203-845-1390
150 GLOVER AVE. SE DECISION MADE: 18-JUL-00
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
UNIVEC, INC. 510(k) NO: K993996(TRADITIONAL)
ATTN: S LEVINSON PHONE NO : 516-777-2000
22 DUBON CT. SE DECISION MADE: 17-JUL-00
FARMINGDALE, NY 11735 510(k) STATEMENT
DEVICE: LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
USA INSTRUMENTS, INC. 510(k) NO: K001582(TRADITIONAL)
ATTN: RONY THOMAS PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 17-JUL-00
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINICAM
VIDEO DENTAL CONCEPTS, INC. 510(k) NO: K001541(TRADITIONAL)
ATTN: CLAUDE BERTHOIN PHONE NO : 904-672-0450
110 EAST GRANADA BOULEVARD SE DECISION MADE: 21-JUL-00
SUITE 208; P.O. BOX 36 510(k) STATEMENT
ORMOND BEACH, FL 32175-0036
DEVICE: RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
VORTRAN MEDICAL TECHNOLOGY 1, INC.510(k) NO: K001430(TRADITIONAL)
ATTN: GORDON A WONG PHONE NO : 916-733-6870
3941 J STREET SE DECISION MADE: 05-JUL-00
SUITE 354 510(k) SUMMARY AVAILABLE FROM FDA
SACRAMENTO, CA 95819
DEVICE: MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, M
VSM TECHNOLOGY INC. 510(k) NO: K002046(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 13TH STREET NW SE DECISION MADE: 21-JUL-00
WASHINGTON, DC 20004-1109 510(k) STATEMENT
DEVICE: SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
W.L. GORE & ASSOCIATES,INC 510(k) NO: K001789(TRADITIONAL)
ATTN: R. LARRY PRATT PHONE NO : 520-779-2771
3450 WEST KILTIE LANE SE DECISION MADE: 06-JUL-00
FLAGSTAFF,, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIFLATOR-40
W.O.M. GMHB 510(k) NO: K001533(SPECIAL)
ATTN: MICHAEL MCGRAIL PHONE NO : 508-337-2188
194 BRANCH STREET SE DECISION MADE: 31-JUL-00
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO AUTOKIT LP(A)/DADE DEMENSION
WAKO CHEMICALS, USA, INC. 510(k) NO: K001919(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 23-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WAKO AUTOKIT LP(A)/ RA,500/1000,
WAKO CHEMICALS, USA, INC. 510(k) NO: K001920(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 23-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WAKO AUTOKIT LP(A)/EXPRESS 550
WAKO CHEMICALS, USA, INC. 510(k) NO: K001921(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 23-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
WAKO CHEMICALS, USA, INC. 510(k) NO: K001929(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 24-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
WAKO CHEMICALS, USA, INC. 510(k) NO: K001931(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 24-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
WAKO CHEMICALS, USA, INC. 510(k) NO: K001933(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 24-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
WAKO CHEMICALS, USA, INC. 510(k) NO: K001934(SPECIAL)
ATTN: TONYA MALLORY PHONE NO : 804-714-1925
1600 BELLWOOD RD. SE DECISION MADE: 24-JUL-00
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: WELCH ALLYN INSTRUMENT INTERFACE MODULE
WELCH ALLYN, INC. 510(k) NO: K001265(TRADITIONAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE STREET RD. SE DECISION MADE: 13-JUL-00
P.O. BOX 220 510(k) SUMMARY AVAILABLE FROM FDA
SKANEATELES FALLS, NY 13153-0220
DEVICE: COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
ZIMMER, INC. 510(k) NO: K001989(SPECIAL)
ATTN: LAURA D WILLIAMS PHONE NO : 219-372-4523
P.O. BOX 708 SE DECISION MADE: 25-JUL-00
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 246
TOTAL WITH SUMMARIES 174
TOTAL WITH STATEMENTS 72
Updated 9/20/2000
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