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510(k)s Final Decisions Rendered for November 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-NOV-2000 THROUGH 30-NOV-2000 DEVICE: GENX CODA INCUBATOR CELLMATE GENX INTL., INC. 510(k) NO: K001600(TRADITIONAL) ATTN: MICHAEL D CECCHI PHONE NO : 800-966-6453 170 FORT PATH RD. SE DECISION MADE: 22-NOV-00 MADISON, CT 06443 510(k) STATEMENT DEVICE: VBMAX A-M SYSTEMS, INC. 510(k) NO: K000654(TRADITIONAL) ATTN: STEVE GRASSER PHONE NO : 360-683-8300 131 BUSINESS PARK LOOP SE DECISION MADE: 14-NOV-00 P.O. BOX 850 510(k) SUMMARY AVAILABLE FROM FDA CARLSBORG, WA 98324 DEVICE: A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 A.R.C. LASER AG 510(k) NO: K002986(TRADITIONAL) ATTN: DANIEL HOEFER PHONE NO : 801-972-1311 2417 SOUTH 3850 WEST SE DECISION MADE: 29-NOV-00 SALT LAKE CITY, UT 84120 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETEST LINEZOLID AB BIODISK 510(k) NO: K002139(TRADITIONAL) ATTN: ANNE BOLMSTORM PHONE NO : 46 8 7300760 DALVAGEN 10, S-169 56 SE DECISION MADE: 08-NOV-00 SOLNA, SWEDEN 510(k) STATEMENT DEVICE: SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP ABBOTT LABORATORIES 510(k) NO: K001993(TRADITIONAL) ATTN: JOE MAGLIOZZI PHONE NO : 781-276-6293 4-A CROSBY DR. SE DECISION MADE: 13-NOV-00 BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL S ACME SPINE, LLC 510(k) NO: K001044(TRADITIONAL) ATTN: TIMOTHY WILLIAMS PHONE NO : 909-352-9862 9980 INDIANA AVENUE SE DECISION MADE: 03-NOV-00 UNIT 9 510(k) SUMMARY AVAILABLE FROM FDA RIVERSIDE, CA 92503 DEVICE: ALLEGRO TB, ALLEGRO N ADAC LABORATORIES 510(k) NO: K003434(TRADITIONAL) ATTN: DAVID KOLESAR PHONE NO : 408-468-3455 540 ALDER DR. SE DECISION MADE: 16-NOV-00 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OS-2000 OPTICAL SONOGRAPHY SYSTEM ADVANCED DIAGNOSTICS, INC. 510(k) NO: K001510(TRADITIONAL) ATTN: STEVE HESLER PHONE NO : 509-375-4029 2400 STEVENS DR., SUITE C SE DECISION MADE: 30-NOV-00 RICHLAND, WA 99352 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVANCED UROSCIENCE INNERSHEATH ADVANCED UROSCIENCE INC. 510(k) NO: K002573(TRADITIONAL) ATTN: KAREN E PETERSON PHONE NO : 651-762-2146 1290 HAMMOND RD. SE DECISION MADE: 16-NOV-00 ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH AGILENT TECHNOLOGIES, INC. 510(k) NO: K002459(TRADITIONAL) ATTN: ROB BUTLER PHONE NO : 978-659-2785 3000 MINUTEMAN RD. SE DECISION MADE: 08-NOV-00 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAMSHIDI MARROW ACQUISITION CRADLE ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K003370(SPECIAL) ATTN: LAVENIA FORD PHONE NO : 847-785-3323 1500 WAUKEGAN RD. SE DECISION MADE: 22-NOV-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPLETE BRAND LUBRICATING AND REWETTING DROPS ALLERGAN, INC. 510(k) NO: K003109(ABBREVIATED) ATTN: PAUL J NOWACKI PHONE NO : 714-246-6761 2525 DUPONT DR. SE DECISION MADE: 21-NOV-00 IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA OMEGA DUAL COOLER-HEATER ALPHA OMEGA, INC. 510(k) NO: K001520(TRADITIONAL) ATTN: RICHARD MARTIN PHONE NO : 512-474-7278 2525 HARTFORD ROAD SE DECISION MADE: 22-NOV-00 AUSTIN, TX 78703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RACE ENDODONTIC FILE AMC GENERAL INCORPORATED 510(k) NO: K002709(TRADITIONAL) ATTN: RAY T BURKE PHONE NO : 912-925-8525 800 KING GEORGE BLVD. SE DECISION MADE: 17-NOV-00 SAVANNAH, GA 31419 510(k) STATEMENT DEVICE: MODIFICATION TO RAPID DRUG SCREEN 9-PANEL AMERICAN BIO MEDICA CORP. 510(k) NO: K002447(TRADITIONAL) ATTN: JOHN B DUBECK PHONE NO : 202-434-4125 1001 G STREET, NW SE DECISION MADE: 16-NOV-00 SUITE 500W 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K002721(TRADITIONAL) ATTN: GINGER Z GLASER PHONE NO : 952-930-6541 10700 BREN RD., WEST SE DECISION MADE: 29-NOV-00 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETALGARD LITE ANALOGIC CORP. 510(k) NO: K002503(TRADITIONAL) ATTN: STEVEN A CLARKE PHONE NO : 978-977-3000 8 CENTENNIAL DRIVE SE DECISION MADE: 09-NOV-00 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPON TAMPON ANOTHERWAY PRODUCTS LLC 510(k) NO: K992493(TRADITIONAL) ATTN: STEVEN A KILGORE PHONE NO : 816-322-7338 910 NORTH WARD RD. SE DECISION MADE: 06-NOV-00 RAYMORE, MO 64083 510(k) STATEMENT DEVICE: RADIAL HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. 510(k) NO: K002644(TRADITIONAL) ATTN: LOUISE M FOCHT PHONE NO : 858-452-8580 9369 CARROLL PARK RD., SUITE A SE DECISION MADE: 20-NOV-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-RAD %CDT TIA AXIS-SHIELD ASA 510(k) NO: K001651(TRADITIONAL) ATTN: RONALD G LEONARDI PHONE NO : 619-586-0751 P.O. BOX 262069 SE DECISION MADE: 22-NOV-00 SAN DIEGO, CA 92196 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 BAXTER HEALTHCARE CORP. 510(k) NO: K001685(TRADITIONAL) ATTN: ROBERT L WILKINSON PHONE NO : 847-473-6335 1620 WAUKEGAN ROAD SE DECISION MADE: 15-NOV-00 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUPLOGRIP BAXTER HEALTHCARE CORP. 510(k) NO: K003193(SPECIAL) ATTN: ARLENE VIDOR PHONE NO : 818-507-5523 550 NORTH BRAND BOULEVARD SE DECISION MADE: 07-NOV-00 GLENDALE, CA 91023 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS ULTRASENSITIVE HGH CALIBRATORS BECKMAN COULTER, INC. 510(k) NO: K003098(TRADITIONAL) ATTN: MARA CALER PHONE NO : 858-621-4583 7330 CARROLL ROAD SE DECISION MADE: 20-NOV-00 P.O. BOX 269006 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92196-9006 DEVICE: SYNCHRON CONTROL BECKMAN COULTER, INC. 510(k) NO: K003488(SPECIAL) ATTN: GAIL LEFEBVRE PHONE NO : 714-993-8503 200 S. KRAEMER BLVD., W-104 SE DECISION MADE: 27-NOV-00 BREA, CA 92822-8000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16" BECTON DICKINSON & CO. 510(k) NO: K002938(TRADITIONAL) ATTN: PETER ZURLO PHONE NO : 201-847-6447 1 BECTON DR. SE DECISION MADE: 29-NOV-00 FRANKLIN LAKES, NJ 07417-1883 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSU BECTON DICKINSON VACUTAINER SYSTEM510(k) NO: K002456(TRADITIONAL) ATTN: JAMES HAYNES PHONE NO : 201-847-5170 ONE BECTON DR SE DECISION MADE: 02-NOV-00 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET BIO-RAD LABORATORIES 510(k) NO: K003030(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 29-NOV-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL BIO-RAD LABORATORIES 510(k) NO: K003239(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 30-NOV-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622 BIO-RAD LABORATORIES 510(k) NO: K003242(TRADITIONAL) ATTN: ELIZABETH PLATT PHONE NO : 949-598-1285 9500 JERONIMO RD. SE DECISION MADE: 30-NOV-00 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCOLOGY SALVAGE SYSTEM BIOMET, INC. 510(k) NO: K002757(TRADITIONAL) ATTN: TINA LAKIN PHONE NO : 219-372-1512 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 24-NOV-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT BIOMET, INC. 510(k) NO: K003131(SPECIAL) ATTN: CAROL LAUSTER PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK, SE DECISION MADE: 02-NOV-00 P.O.BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46580 DEVICE: BIOMET LATERAL TROCH PLATE BIOMET, INC. 510(k) NO: K003294(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 219-372-1761 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 03-NOV-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIOMET SCK KNEE SYSTEM BIOMET, INC. 510(k) NO: K003296(SPECIAL) ATTN: TRACY J BICKEL PHONE NO : 219-372-1761 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 06-NOV-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: ISS OFFSET HEADS BIOMET, INC. 510(k) NO: K003428(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 800-348-9500 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 24-NOV-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL BIOMET, INC. 510(k) NO: K003429(SPECIAL) ATTN: DALENE T BINKLEY PHONE NO : 219-372-1612 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 30-NOV-00 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: RENEW LS-1 BISCO, INC. 510(k) NO: K003317(TRADITIONAL) ATTN: CINDY ORIS PHONE NO : 847-534-6000 1100 WEST IRVING PARK RD. SE DECISION MADE: 21-NOV-00 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RENEW LS-2 BISCO, INC. 510(k) NO: K003361(TRADITIONAL) ATTN: CYNDY ORIS PHONE NO : 847-534-6000 1100 WEST IRVING PARK RD. SE DECISION MADE: 28-NOV-00 SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVALIS (SHAPED BEAM SURGERY SYSTEM) BRAINLAB AG 510(k) NO: K002509(TRADITIONAL) ATTN: STEFAN VILSMEIER PHONE NO : 498 999 15680 AMMERTHALSTRASSE 8 SE DECISION MADE: 03-NOV-00 HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST BRANAN MEDICAL CORP. 510(k) NO: K002263(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 714-557-2285 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 27-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL BRANAN MEDICAL CORP. 510(k) NO: K002272(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 22-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST BRANAN MEDICAL CORPORAION 510(k) NO: K002264(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 714-557-2285 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 27-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN BRANAN MEDICAL CORPORAION 510(k) NO: K002265(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 714-557-2285 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 27-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST BRANAN MEDICAL CORPORAION 510(k) NO: K002266(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 22-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TE BRANAN MEDICAL CORPORAION 510(k) NO: K002268(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 27-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TES BRANAN MEDICAL CORPORAION 510(k) NO: K002337(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 22-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST BRANAN MEDICAL CORPORAION 510(k) NO: K002342(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 27-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TEST, BRANAN MEDICAL CORPORAION 510(k) NO: K002417(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 22-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TES BRANAN MEDICAL CORPORAION 510(k) NO: K002418(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 22-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE 500 DRUG SCR BRANAN MEDICAL CORPORAION 510(k) NO: K002587(TRADITIONAL) ATTN: RAPHAEL WONG PHONE NO : 949-598-7166 10015 MUIRLANDS RD. SUITE E SE DECISION MADE: 22-NOV-00 IRVINE, CA 92618 510(k) STATEMENT DEVICE: BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOT BRENTWOOD MEDICAL TECHNOLOGY CORP.510(k) NO: K002499(TRADITIONAL) ATTN: GLEN MIZELLE PHONE NO : 310-530-5955 3300 FUJITA STREET SE DECISION MADE: 08-NOV-00 TORRANCE, CA 90505 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANDELA MID IR DIODE LASER SYSTEM CANDELA CORP. 510(k) NO: K002421(TRADITIONAL) ATTN: JOAN CLIFFORD PHONE NO : 508-358-7637 530 BOSTON POST RD. SE DECISION MADE: 03-NOV-00 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PERSONAL ECG TRANSMITTER, MODEL CG-6550 CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K003220(SPECIAL) ATTN: LEONID TRACHTENBERG PHONE NO : 972 8 9484600 2 PEKERIS STREET SE DECISION MADE: 08-NOV-00 REHOVOT, ISRAEL 510(k) STATEMENT DEVICE: AB-180 XC SYSTEM, MODEL AB-180XC CARDIAC ASSIST TECHNOLOGIES, INC. 510(k) NO: K991783(TRADITIONAL) ATTN: RICHARD G CONFER PHONE NO : 412-963-7770 240 ALPHA DR. SE DECISION MADE: 01-NOV-00 PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CN ACQUISITION STATION CARDIONOW, INC. 510(k) NO: K002597(TRADITIONAL) ATTN: JOHNNY M GARZA PHONE NO : 760-633-9797 535 ENCINITAS BLVD. SE DECISION MADE: 17-NOV-00 SUITE 118 510(k) SUMMARY AVAILABLE FROM FDA ENCINITAS, CA 92024 DEVICE: CARESIDE CHOLINESTERASE CARESIDE HEMOTOLOGY, INC. 510(k) NO: K002792(TRADITIONAL) ATTN: KENNETH B ASARCH PHONE NO : 310-338-6767 6100 BRISTOL PARKWAY SE DECISION MADE: 08-NOV-00 CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIE CBS INTL. B.V. 510(k) NO: K002693(TRADITIONAL) ATTN: PATRICIA E JANSEN PHONE NO : 31 365 302005 GROTE MARKET 3-5 SE DECISION MADE: 09-NOV-00 ALMERE, NETHERLANDS 1315 JA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN COBE CARDIOVASCULAR, INC. 510(k) NO: K002493(TRADITIONAL) ATTN: LYNNE LEONARD PHONE NO : 303-467-6586 14401 WEST 65TH WAY SE DECISION MADE: 30-NOV-00 ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLTENE AURA COMPOMER RESTORATIVE SYSTEM COLTENE/WHALEDENT INC. 510(k) NO: K003034(TRADITIONAL) ATTN: H. J VOGELSTEIN PHONE NO : 201-512-8000 750 CORPORATE DR. SE DECISION MADE: 30-NOV-00 MAHWAH, NJ 07430-2009 510(k) STATEMENT DEVICE: HERMES PORT EXPANDER COMPUTER MOTION, INC. 510(k) NO: K003217(SPECIAL) ATTN: DAVID U THOMAS PHONE NO : 805-968-9600 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 03-NOV-00 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. 510(k) NO: K003222(SPECIAL) ATTN: DAVID U THOMAS PHONE NO : 805-968-9600 130 CREMONA DRIVE, SUITE B SE DECISION MADE: 03-NOV-00 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELI CONCEPT RUBBER PRODUCTS SDN BHD 510(k) NO: K003213(TRADITIONAL) ATTN: TEOH HUN LIM PHONE NO : 04 551 5299 2050 JALAN ALMA SE DECISION MADE: 29-NOV-00 BUKIT MERTAJAM, 510(k) STATEMENT SEBERANG PERAI, PENANG, MALAYSIA 14000 DEVICE: QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 CONSOLIDATED TECHNOLOGIES OF WISCO510(k) NO: K001249(TRADITIONAL) ATTN: RUSTY SEWELL PHONE NO : 512-445-5100 2170 WOODWARD STREET SE DECISION MADE: 02-NOV-00 AUSTIN, TX 78744-1832 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM COOK, INC. 510(k) NO: K000651(TRADITIONAL) ATTN: LISA WEBB PHONE NO : 800-346-2686 925 SOUTH CURRY PIKE SE DECISION MADE: 24-NOV-00 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER COOK, INC. 510(k) NO: K002288(TRADITIONAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 28-NOV-00 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYS CORDIS CORP. 510(k) NO: K003336(SPECIAL) ATTN: ELENA S JUGO PHONE NO : 305-824-2531 14201 N.W. 60TH AVE. SE DECISION MADE: 22-NOV-00 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) CORDIS CORP. 510(k) NO: K003365(SPECIAL) ATTN: SAM MIRZA PHONE NO : 305-824-2402 14201 N.W. 60TH AVE. SE DECISION MADE: 22-NOV-00 MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CBS STRAW CRYO BIO SYSTEM 510(k) NO: K002595(TRADITIONAL) ATTN: GABRIELE LINGENOLELE PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 17-NOV-00 IRVINE, CA 92606 510(k) STATEMENT DEVICE: ECAT ACCEL PET SCANNER CTI PET SYSTEMS, INC. 510(k) NO: K002584(TRADITIONAL) ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522 810 INNOVATION DR. SE DECISION MADE: 16-NOV-00 KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEHRING COAGULATION SYSTEM, MODEL BCS DADE BEHRING, INC. 510(k) NO: K002080(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-392-5639 7739 NW 48 STREET SE DECISION MADE: 16-NOV-00 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33166 DEVICE: N LATEX B2-MICROGLOBULIN DADE BEHRING, INC. 510(k) NO: K002731(TRADITIONAL) ATTN: RADAMES RIESGO PHONE NO : 305-392-5639 7739 NW 48 STREET SE DECISION MADE: 20-NOV-00 SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA MIAMI, FL 33166 DEVICE: N/T PROTEIN CONTROL SL DADE BEHRING, INC. 510(k) NO: K002852(TRADITIONAL) ATTN: REBECCA S AYASH PHONE NO : 302-631-6276 GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 27-NOV-00 BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA P.O. BOX 6101, NEWARK, DE 19714-6101 DEVICE: ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 DAIG CORP. 510(k) NO: K000004(TRADITIONAL) ATTN: PAUL CORNELISON PHONE NO : 612-933-4700 14901 DEVEAU PL. SE DECISION MADE: 29-NOV-00 MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PE.R.I. II KNEE FRACTURE SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K003235(TRADITIONAL) ATTN: MARCIA J ARENTZ PHONE NO : 219-371-4944 700 ORTHOPAEDIC DR. SE DECISION MADE: 06-NOV-00 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINIFLO INCENTIVE SPIROMETER DHD HEALTHCARE CORP. 510(k) NO: K003146(TRADITIONAL) ATTN: LAWRENCE WEINSTEIN PHONE NO : 315-363-2330 ONE MADISON STREET SE DECISION MADE: 21-NOV-00 WAMPSVILLE, NY 13163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K003093(TRADITIONAL) ATTN: KAREN CALLBECK PHONE NO : 902 566 1396 16 MCCARVILLE STREET SE DECISION MADE: 27-NOV-00 CHARLOTTETOWN, CANADA C1E 2A6 510(k) STATEMENT DEVICE: DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM DIAMEDIX CORP. 510(k) NO: K002262(TRADITIONAL) ATTN: LYNNE STIRLING PHONE NO : 305-324-2354 2140 NORTH MIAMI AVE. SE DECISION MADE: 28-NOV-00 MIAMI, FL 33127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIA DOCTOR'S RESEARCH GROUP, INC. 510(k) NO: K002047(TRADITIONAL) ATTN: RICHARD DESLAURIERS PHONE NO : 203-879-9422 143 WOLCOTT ROAD SE DECISION MADE: 22-NOV-00 WOLCOTT, CT 06716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INVAC DUNCAN HYND ASSOCIATES, LTD. 510(k) NO: K002608(TRADITIONAL) ATTN: DIANA UPTON PHONE NO : 201-692-1945 719 CATALPA AVENUE SE DECISION MADE: 16-NOV-00 TEANECK, NJ 07666 510(k) STATEMENT DEVICE: DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMM ELSCINTEC SYSTEMS LTD. 510(k) NO: K003473(TRADITIONAL) ATTN: ELLIOT MARSHALL PHONE NO : 972 481 31403 MATAM-ADVANCED TECH. CENTER SE DECISION MADE: 28-NOV-00 HAIFA, ISRAEL 31000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL SYSTEM WITH CRYOGUIDE ENDOCARE, INC. 510(k) NO: K002615(TRADITIONAL) ATTN: VINCENT CUTARELLI PHONE NO : 949-595-5424 7 STUDEBAKER SE DECISION MADE: 13-NOV-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE PRESSURE MONITOR ENGINEERED MEDICAL SYSTEMS 510(k) NO: K003497(TRADITIONAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 30-NOV-00 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERIC INJECTION CATHETER WITH IRRIGATION ENTERIC MEDICAL TECHNOLOGIES, INC.510(k) NO: K002778(TRADITIONAL) ATTN: JILL M VISOR PHONE NO : 650-574-2867 1125 EAST HILLSDALE BLVD. SE DECISION MADE: 22-NOV-00 SUITE 106 510(k) STATEMENT FOSTER CITY, CA 94404 DEVICE: PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI ENTERIC PRODUCTS, INC. 510(k) NO: K001177(TRADITIONAL) ATTN: JEFFREY PEACOCK PHONE NO : 800-233-8583 25 EAST LOOP DR., SE DECISION MADE: 13-NOV-00 BIOTECH. INCUBATOR- RM. 102 510(k) STATEMENT STONY BROOK, NY 11794-3355 DEVICE: ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 ERECORDS ENTERPRISES 510(k) NO: K001788(TRADITIONAL) ATTN: ED GOSS PHONE NO : 416 383 0046 801 YORK MILLS ROAD SE DECISION MADE: 03-NOV-00 SUITE 314 510(k) SUMMARY AVAILABLE FROM FDA TORONTO, CANADA DEVICE: ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, E ETHICON ENDO-SURGERY, INC. 510(k) NO: K002398(TRADITIONAL) ATTN: EDWIN O BILLIPS PHONE NO : 513-337-7162 4545 CREEK RD. SE DECISION MADE: 03-NOV-00 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGIC ETHICON, INC. 510(k) NO: K002672(TRADITIONAL) ATTN: KAREN LESSIG PHONE NO : 908-218-2445 ROUTE 22 WEST P.O. BOX 151 SE DECISION MADE: 22-NOV-00 SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHIBOND EXCEL VALVE LOOP SUTURE ETHICON, INC. 510(k) NO: K003070(TRADITIONAL) ATTN: GREGORY R JONES PHONE NO : 908-218-2481 P.O. BOX 151 SE DECISION MADE: 07-NOV-00 SOMERVILLE, NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE-VINYL EXAM GLOVE, POWDERED EXCELLENCE ENT. CO., LTD. 510(k) NO: K003133(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 07-NOV-00 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT CORD IQ OPTION 1.0 GE MEDICAL SYSTEM 510(k) NO: K003408(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 16800 RYERSON ROAD SE DECISION MADE: 17-NOV-00 NEW BERLIN, WI 53151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSETTA-LT/ROSETTA-RX GENERAL DEVICES 510(k) NO: K002089(TRADITIONAL) ATTN: MICHAEL SMITH PHONE NO : 201-313-7075 1000 RIVER ST. SE DECISION MADE: 21-NOV-00 RIDGEFIELD, NJ 07657 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXTSTITCH CARDIOVASCULAR VALVE SUTURE GENZYME SURGICAL PRODUCT (GENZYME 510(k) NO: K001440(TRADITIONAL) ATTN: MARY E GRAY PHONE NO : 508-677-6512 600 AIRPORT RD. SE DECISION MADE: 13-NOV-00 FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RES GIMBEL GLOVE CO., LLC 510(k) NO: K003063(TRADITIONAL) ATTN: GORDON P PARDY PHONE NO : 888-667-8425 10640 NORTH 28TH DR. SE DECISION MADE: 22-NOV-00 SUITE A-200 510(k) STATEMENT PHOENIX, AZ 85029 DEVICE: HARDYDISK CLINDAMYCIN, 2MCG HARDY DIAGNOSTICS 510(k) NO: K002662(TRADITIONAL) ATTN: MELISSA M TRAYLOR PHONE NO : 805-346-2766 1430 WEST MCCOY LANE SE DECISION MADE: 02-NOV-00 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM HARTALEGA SDN BHD 510(k) NO: K002593(TRADITIONAL) ATTN: NURUL A KONG PHONE NO : 603 634 2177 9 JALAN KANAN TAMAN KEPONG SE DECISION MADE: 29-NOV-00 INDUSTRIAL ESTATE 510(k) STATEMENT KUALA LUMPUR, MALAYSIA 52100 DEVICE: COLOSCREEN-ES HELENA LABORATORIES 510(k) NO: K003359(TRADITIONAL) ATTN: PAT FRANKS PHONE NO : 409-842-3714 1530 LINDBERGH DR. SE DECISION MADE: 27-NOV-00 P.O. BOX 752 510(k) STATEMENT BEAUMONT, TX 77704 DEVICE: RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; HILL-ROM AIR-SHIELDS 510(k) NO: K003335(SPECIAL) ATTN: LARRY W KRASLEY PHONE NO : 215-675-5200 330 JACKSONVILLE RD. SE DECISION MADE: 17-NOV-00 HATBORO, PA 19040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A HMI INDUSTRIES, INC. 510(k) NO: K002692(TRADITIONAL) ATTN: JACQUELINE A PURCELL PHONE NO : 216-986-8019 13325 DARICE PARKWAY, UNIT A SE DECISION MADE: 17-NOV-00 STRONGSVILLE, OH 44149 510(k) STATEMENT DEVICE: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE HOWMEDICA OSTEONICS CORP. 510(k) NO: K002552(TRADITIONAL) ATTN: JENNIFER A DAUDELIN PHONE NO : 201-507-7283 359 VETERANS BOULEVARD SE DECISION MADE: 13-NOV-00 RUTHERFORD, NJ 07070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP. 510(k) NO: K003379(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 30-NOV-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEONICS ALUMINA C-TAPER HEAD HOWMEDICA OSTEONICS CORP. 510(k) NO: K003391(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 28-NOV-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALUMINA V40 HEAD HOWMEDICA OSTEONICS CORP. 510(k) NO: K003413(SPECIAL) ATTN: KAREN ARIEMMA PHONE NO : 201-760-8187 59 ROUTE 17 SE DECISION MADE: 24-NOV-00 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, HUDSON RESPIRATORY CARE, INC. 510(k) NO: K001213(TRADITIONAL) ATTN: DANA HOUGHTON PHONE NO : 909-676-5611 27711 DIAZ RD. SE DECISION MADE: 03-NOV-00 P.O. BOX 9020 510(k) SUMMARY AVAILABLE FROM FDA TEMECULA, CA 92589 DEVICE: MAGNA TEK ESU-400 HUTTINGER MEDIZINTECHNIK GMBH & CO510(k) NO: K003471(TRADITIONAL) ATTN: BERNHARD HUG PHONE NO : 490 766 598020 AM GANSACKER 1B SE DECISION MADE: 20-NOV-00 UMKIRCH, GERMANY 79224 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR HYDROCISION, INC. 510(k) NO: K002764(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-435-9893 7 TIFFANY SE DECISION MADE: 24-NOV-00 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM HYPERTENSION DIAGNOSTICS, INC. 510(k) NO: K001948(TRADITIONAL) ATTN: CHARLES F CHESNEY PHONE NO : 651-687-9999 2915 WATERS ROAD SE DECISION MADE: 01-NOV-00 SUITE 108 510(k) SUMMARY AVAILABLE FROM FDA EAGAN, MN 55121-1562 DEVICE: IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) IMPLANTECH ASSOCIATES, INC. 510(k) NO: K002886(TRADITIONAL) ATTN: EDWARD LEICHT PHONE NO : 805-339-9415 2064 EASTMAN AVE., UNIT 101 SE DECISION MADE: 24-NOV-00 VENTURA, CA 93003 510(k) STATEMENT DEVICE: IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY IMPLEX CORP. 510(k) NO: K003181(SPECIAL) ATTN: JOHN SCHALAGO PHONE NO : 201-818-1800 80 COMMERCE DR. SE DECISION MADE: 07-NOV-00 ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRIENDLY LIGHT ER:YAG PULSED LASER INNOTECH USA, INC 510(k) NO: K000023(TRADITIONAL) ATTN: THOMAS BECZE PHONE NO : 609-951-9596 116 VILLAGE BOULEVARD SE DECISION MADE: 06-NOV-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA PRINCETON, NJ 08540-5799 DEVICE: LITWIN CRUICATE ANCHOR INSTRUMENT MAKAR, INC. 510(k) NO: K002600(TRADITIONAL) ATTN: LANNY L JOHNSON PHONE NO : 517-332-3593 2950 EAST MT. HOPE RD. SE DECISION MADE: 15-NOV-00 OKEMOS, MI 48864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELTA 32 AND DELTA 32 TACT INSTRUMENTARIUM IMAGING, INC. 510(k) NO: K002472(TRADITIONAL) ATTN: TOMMI JOKINIEMI PHONE NO : 414-747-1030 300 WEST EDGERTON AVE. SE DECISION MADE: 29-NOV-00 MILWAUKEE, WI 53207-6025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, INTEGRA NEUROCARE LLC 510(k) NO: K002392(TRADITIONAL) ATTN: NANCY MATHEWSON PHONE NO : 858-455-1115 5955 PACIFIC CENTER BLVD. SE DECISION MADE: 02-NOV-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB L INTEGRA NEUROSCIENCES 510(k) NO: K002765(TRADITIONAL) ATTN: NANCY MATHEWSON PHONE NO : 858-455-1115 5955 PACIFIC CENTER BLVD. SE DECISION MADE: 24-NOV-00 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTSENS INTEGRATED BIOSENSING TECHNOLOGIES510(k) NO: K001521(TRADITIONAL) ATTN: RONALD LUICH PHONE NO : 860-437-4609 86 BOSTON POST ROAD SE DECISION MADE: 27-NOV-00 WATERFORD, CT 06385 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT INTRACEL CORP. 510(k) NO: K003204(SPECIAL) ATTN: SHANE WARD PHONE NO : 301-258-5200 1330 PICCARD DR. SE DECISION MADE: 07-NOV-00 ROCKVILLE, MD 20850-4396 510(k) STATEMENT DEVICE: R&D PROJECT DW271#11A IVOCLAR NORTH AMERICA, INC. 510(k) NO: K002872(TRADITIONAL) ATTN: ANDY GULATI PHONE NO : 716-691-0010 175 PINEVIEW DR. SE DECISION MADE: 02-NOV-00 AMHERST, NY 14228 510(k) STATEMENT DEVICE: PROCAD ADD-ON IVOCLAR NORTH AMERICA, INC. 510(k) NO: K003373(TRADITIONAL) ATTN: ANDY GULATI PHONE NO : 800-533-6825 175 PINEVIEW DR. SE DECISION MADE: 28-NOV-00 AMHERST, NY 14228 510(k) STATEMENT DEVICE: EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL J. H. EMERSON CO. 510(k) NO: K002598(SPECIAL) ATTN: GEORGE EMERSON PHONE NO : 617-864-1414 22 COTTAGE PARK AVE. SE DECISION MADE: 22-NOV-00 CAMBRIDGE, MA 02140-1691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "FREEDOM" AUTOMATIC FILM PROCESSOR J. MORITA USA, INC. 510(k) NO: K002640(ABBREVIATED) ATTN: VICTOR MAZZANTI PHONE NO : 800-831-3222 9 MASON SE DECISION MADE: 08-NOV-00 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HERACERAM J.F. JELENKO & CO., INC. 510(k) NO: K002993(TRADITIONAL) ATTN: RAPHAEL JUDKINS PHONE NO : 800-431-1785 99 BUSINESS PARK DR. SE DECISION MADE: 16-NOV-00 ARMONK, NY 10504 510(k) STATEMENT DEVICE: SELF ETCH BONDING PRIMER JENERIC/PENTRON, INC. 510(k) NO: K003011(TRADITIONAL) ATTN: ANUMARIE TENERO PHONE NO : 203-265-7397 53 NORTH PLAINS INDUSTRIAL RD SE DECISION MADE: 28-NOV-00 WALLINGFORD, CT 06492-0724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WILLI GELLER CREATION AND LF PORCELAIN JENSEN INDUSTRIES, INC. 510(k) NO: K002904(TRADITIONAL) ATTN: JOHN SLANSKI PHONE NO : 203-239-2090 50 STILLMAN RD. SE DECISION MADE: 06-NOV-00 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES, YELLOW KAOHSIUNG BROTHERS PRODUCTS CORP. 510(k) NO: K003197(TRADITIONAL) ATTN: STONE CHEN PHONE NO : 886 07 5612201 23 KOOSHAN 3RD RD. SE DECISION MADE: 22-NOV-00 KAOHSIUNG, CHINA (TAIWAN) 80414 510(k) STATEMENT DEVICE: KARL STORZ HYSTEROMAT II KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K000806(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 30-NOV-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KSEA MINIATURE NEUROENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K002704(TRADITIONAL) ATTN: KEVIN KENNAN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 03-NOV-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K002924(TRADITIONAL) ATTN: KEVIN KENNEN PHONE NO : 310-410-2769 600 CORPORATE POINTE SE DECISION MADE: 03-NOV-00 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KM-10 TENS ELECTRODE KATECHO, INC. 510(k) NO: K000870(TRADITIONAL) ATTN: WARREN R WALTERS PHONE NO : 515-244-1212 2500 BELL AVE. SE DECISION MADE: 07-NOV-00 P.O. BOX 21247 510(k) STATEMENT DES MOINES, IA 50321 DEVICE: K-DEFIB/PACE, MODEL KDP-60A KATECHO, INC. 510(k) NO: K002806(TRADITIONAL) ATTN: WARREN R WALTERS PHONE NO : 515-244-1212 2500 BELL AVE. SE DECISION MADE: 21-NOV-00 DES MOINES, IA 50321 510(k) STATEMENT DEVICE: KAVO CORUND HANDPIECE 2013 KAVO AMERICA 510(k) NO: K002708(TRADITIONAL) ATTN: JOHN WESTERMEIER PHONE NO : 847-550-6800 340 EAST MAIN STREET SE DECISION MADE: 28-NOV-00 LAKE ZURICH, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDRO HERACELL CO2 INCUBATOR KENDRO LABORATORY PRODUCTS, L.P. 510(k) NO: K002805(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD.; SUITE 200 SE DECISION MADE: 09-NOV-00 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SSW-STERILE SOLUTION WARMER KMI KOLSTER METHODS INC. 510(k) NO: K002859(TRADITIONAL) ATTN: ALWIN H KOLSTER PHONE NO : 714-956-1964 708 NORTH VALLEY, SUITE N SE DECISION MADE: 16-NOV-00 ANAHEIM, CA 92801 510(k) STATEMENT DEVICE: QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H LSI INTL., INC. 510(k) NO: K002390(TRADITIONAL) ATTN: JAMES C LANES PHONE NO : 913-894-4493 8849 BOND SE DECISION MADE: 02-NOV-00 OVERLAND PARK, KS 66214 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DIS MALLINCKRODT, INC. 510(k) NO: K003315(SPECIAL) ATTN: JAMES C KEEVEN PHONE NO : 636-498-3431 3 MISSOURI RESEARCH PARK DRIVE SE DECISION MADE: 08-NOV-00 ST. CHARLES, MO 63304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES MASIMO CORP. 510(k) NO: K003167(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 08-NOV-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE MASIMO CORP. 510(k) NO: K003244(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 08-NOV-00 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND MEDICAL CABLES, INC. 510(k) NO: K002781(ABBREVIATED) ATTN: CHRISTOPHER FONTANA PHONE NO : 714-545-3469 1340 LOGAN AVE. SE DECISION MADE: 29-NOV-00 COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. 510(k) NO: K003525(TRADITIONAL) ATTN: GARY ALLSEBROOK PHONE NO : 714-889-3000 6616 OWENS DR. SE DECISION MADE: 22-NOV-00 PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE MEDLINE INDUSTRIES, INC. 510(k) NO: K003353(TRADITIONAL) ATTN: LARA N SIMMONS PHONE NO : 847-949-2639 ONE MEDLINE PL. SE DECISION MADE: 22-NOV-00 MUNDELEIN, IL 60060-4486 510(k) STATEMENT DEVICE: MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 MEDMIRA LABORATORIES INC. 510(k) NO: K002023(TRADITIONAL) ATTN: TODD BISHOP PHONE NO : 902 450 1588 155 CHAIN LAKE DR. SE DECISION MADE: 13-NOV-00 HALIFAX, N.S., CANADA B3S 1B3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDOVATIONS ESOPHAGEAL DILATOR MEDOVATIONS, INC. 510(k) NO: K002363(TRADITIONAL) ATTN: MICHAEL J BROWN PHONE NO : 847-419-0090 1294 BARCLAY BLVD. SE DECISION MADE: 01-NOV-00 BUFFALO GROVE, IL 60089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRONT-LOAD POLYPROPYLENE SYRINGE MEDRAD, INC. 510(k) NO: K001663(TRADITIONAL) ATTN: FRANK W PELC III PHONE NO : 412-767-2400 ONE MEDRAD DRIVE SE DECISION MADE: 16-NOV-00 INIANOLA,, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 22 MEDTRONIC PS MEDICAL 510(k) NO: K002572(ABBREVIATED) ATTN: JANET MCAULEY PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 16-NOV-00 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METRX SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K002931(TRADITIONAL) ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 24-NOV-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLICITY SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, USA 510(k) NO: K002103(TRADITIONAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 02-NOV-00 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 MERCURY MEDICAL 510(k) NO: K001714(TRADITIONAL) ATTN: RON RUPENSKI PHONE NO : 800-237-6418 11300 49TH ST. NORTH SE DECISION MADE: 03-NOV-00 CLEARWATER, FL 33762-4800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIDIAN-II AND MERDIAN-PLUS MERIDIAN CO., LTD. 510(k) NO: K001347(TRADITIONAL) ATTN: ANDREW PAENG PHONE NO : 573-225-7700 P.O. BOX 3415 SE DECISION MADE: 03-NOV-00 ST.LOUIS, MO 63143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRIS RETRACTING PHACOEMULSIFICATION SLEEVE MICHAEL REYNARD, M.D. 510(k) NO: K002812(TRADITIONAL) ATTN: MICHAEL REYNARD PHONE NO : 310-453-0551 1301-20TH ST., #260 SE DECISION MADE: 08-NOV-00 SANTA MONICA, CA 90404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAGINAL APPLICATOR SHIELDED MICK RADIO-NUCLEAR INSTRUMENTS, IN510(k) NO: K001544(TRADITIONAL) ATTN: FELIX MICK PHONE NO : 718-597-3999 1470 OUTLOOK AVE. SE DECISION MADE: 17-NOV-00 BRONX, NY 10465 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1D MICROLIFE CORP. 510(k) NO: K003308(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD. SE DECISION MADE: 14-NOV-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: AMT SPINAL SYSTEM MICRON PRECISION ENGINEERING, INC.510(k) NO: K002059(TRADITIONAL) ATTN: FRANK E BAILY PHONE NO : 310-831-1873 939 EVENING SHADE DRIVE SE DECISION MADE: 13-NOV-00 SAN PEDRO, CA 90731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 6900GE-64: C-SPINE ARRAY MIDWEST R.F. LLC 510(k) NO: K002860(TRADITIONAL) ATTN: RALPH S HASHOIAN PHONE NO : 262-367-6925 535 NORTON DR. SE DECISION MADE: 22-NOV-00 HARTLAND, WI 53029 510(k) STATEMENT DEVICE: MODEL 6600GE-64: TRAMA NECK ARRAY MIDWEST R.F. LLC 510(k) NO: K002864(TRADITIONAL) ATTN: RALPH S HASHOIAN PHONE NO : 262-367-6925 535 NORTON DR. SE DECISION MADE: 21-NOV-00 HARTLAND, WI 53029 510(k) STATEMENT DEVICE: HRH-63 HEAD ARRAY COIL MRI DEVICES CORP. 510(k) NO: K002774(TRADITIONAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 16-NOV-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: QWH-149 WRIST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K003331(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 08-NOV-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: OBC-149 BREAST ARRAY COIL MRI DEVICES CORP. 510(k) NO: K003340(SPECIAL) ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402 1515 PARAMOUNT DRIVE SE DECISION MADE: 08-NOV-00 WAUKESHA, WI 53186 510(k) STATEMENT DEVICE: ALLON 2001 MODIFIED MTRE ADVANCED TECHNOLOGY LTD. 510(k) NO: K003349(SPECIAL) ATTN: PAUL DRYDEN PHONE NO : 317-335-3780 6329 W. WATERVIEW CT. SE DECISION MADE: 13-NOV-00 MCCORDSVILLE, IN 46055 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL K7 EVALUATION DEVICE MYOTRONICS-NOROMED, INC. 510(k) NO: K003287(SPECIAL) ATTN: FRAY ADIB PHONE NO : 206-243-4214 15425 53RD AVE. SOUTH SE DECISION MADE: 06-NOV-00 TUKWILA, WA 98188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR NARISHIGE CO., LTD. 510(k) NO: K003298(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 21-NOV-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR NARISHIGE CO., LTD. 510(k) NO: K003300(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-NOV-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IM-5A INJECTOR NARISHIGE CO., LTD. 510(k) NO: K003302(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-NOV-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IM-5B MICROINJECTOR NARISHIGE CO., LTD. 510(k) NO: K003303(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-NOV-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IM-6 MICROINJECTOR NARISHIGE CO., LTD. 510(k) NO: K003304(TRADITIONAL) ATTN: MITSUKO YONEYAMA PHONE NO : 813 330 88383 27-9 MINAMIKARASUYAMA 4-CHOME SE DECISION MADE: 22-NOV-00 SETAGAY-KU, TOKYO, JAPAN 157-0062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUWELL TSH, MODEL KAW-TSH-960 NEOMETRICS, INC. 510(k) NO: K001455(TRADITIONAL) ATTN: DAVID SCHWARTZ PHONE NO : 516-754-8080 104 BELLEROSE AVE. SE DECISION MADE: 02-NOV-00 EAST NORTHPORT, NY 11731 510(k) STATEMENT DEVICE: SCAN LT40 (40 CHANNELS) NEURO SCAN LABS 510(k) NO: K001564(TRADITIONAL) ATTN: DAVID B JONES PHONE NO : 915-845-5600 5700 CROMO DR., SUITE 100 SE DECISION MADE: 24-NOV-00 EL PASO, TX 79912-5538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 NEUROSOFT, INC. 510(k) NO: K001692(TRADITIONAL) ATTN: DAVID B JONES PHONE NO : 915-845-5600 5700 CROMO, SUITE 100 SE DECISION MADE: 24-NOV-00 EL PASO, TX 79912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICOLET VASOGUARD NICOLET VASCULAR INC. 510(k) NO: K002766(ABBREVIATED) ATTN: DAVID W WAGNER PHONE NO : 303-431-9400 6355 JOYCE DR. SE DECISION MADE: 30-NOV-00 GOLDEN, CO 80403 510(k) STATEMENT DEVICE: PURESPERM 40 AND PURESPERM 80 NIDACON INTERNATIONAL AB 510(k) NO: K002623(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 P.O. BOX 7007 SE DECISION MADE: 20-NOV-00 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURESPERM WASH NIDACON INTERNATIONAL AB 510(k) NO: K002630(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 21-NOV-00 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CNS-9300 SERIES CENTRAL STATION NIHON KOHDEN AMERICA, INC. 510(k) NO: K001433(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-250-3959 2601 CAMPUS DR. SE DECISION MADE: 07-NOV-00 IRVINE, CA 92612-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES NIHON KOHDEN AMERICA, INC. 510(k) NO: K002473(TRADITIONAL) ATTN: BONNIE BISHOP PHONE NO : 949-580-1555 90 ICON STREET SE DECISION MADE: 08-NOV-00 FOOTHILL RANCH, CA 92610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K003444(TRADITIONAL) ATTN: ROBERT D WAXHAM PHONE NO : 757-365-0978 222 INSTITUTE ST. SE DECISION MADE: 21-NOV-00 SMITHFIELD, VA 23430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO SAFETOUCH SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP. 510(k) NO: K002813(TRADITIONAL) ATTN: RICHARD D BLISS PHONE NO : 954-385-1690 510 STONEMONT DRIVE SE DECISION MADE: 21-NOV-00 WESTON, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPLACE TPS COATED IMPLANTS NOBEL BIOCARE USA, INC. 510(k) NO: K002475(TRADITIONAL) ATTN: DON KENNARD PHONE NO : 714-282-5071 22895 EASTPARK DR. SE DECISION MADE: 09-NOV-00 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC ECG 1200 NORAV MEDICAL LTD. 510(k) NO: K000404(TRADITIONAL) ATTN: STEVE SPRINGROSE PHONE NO : 612-559-4794 12505 58TH AVE. N. SE DECISION MADE: 22-NOV-00 PLYMOUTH, MN 55442 510(k) STATEMENT DEVICE: NUMALINK NUMA, INC. 510(k) NO: K002724(TRADITIONAL) ATTN: LARRY SMITH PHONE NO : 603-883-1909 10 NORTHERN BLVD., UNIT 12 SE DECISION MADE: 17-NOV-00 AMHERST, NH 03031 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUMED TYSHAK II AND Z-MED II PTV CATHETERS NUMED, INC. 510(k) NO: K003052(SPECIAL) ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491 P.O BOX 129 SE DECISION MADE: 01-NOV-00 NICHOLVILLE, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUMED TYSHAK AND Z-MED PTV CATHETERS NUMED, INC. 510(k) NO: K003114(SPECIAL) ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491 P.O BOX 129 SE DECISION MADE: 01-NOV-00 NICHOLVILLE, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM NUVASIVE, INC. 510(k) NO: K002677(TRADITIONAL) ATTN: R. STEPHEN REITZLER PHONE NO : 858-271-7070 10065 OLD GROVE RD., SUITE A SE DECISION MADE: 13-NOV-00 SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (H OCU-EASE OPTICAL PRODUCTS, INC. 510(k) NO: K002966(TRADITIONAL) ATTN: CHARLES R VERNETTE PHONE NO : 510-724-0384 629 TENNENT AVE. SE DECISION MADE: 08-NOV-00 PINOLE, CA 94564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: O-PERM 30 OPTICAL POLYMER RESEARCH, INC. 510(k) NO: K002703(TRADITIONAL) ATTN: WERNER P SCHUMAN PHONE NO : 352-378-1027 5921 NORTHEAST 38TH STREET SE DECISION MADE: 21-NOV-00 GAINESVILLE, FL 32609-1515 510(k) STATEMENT DEVICE: SURESMILE SYSTEM ORA METRIX, INC. 510(k) NO: K002620(TRADITIONAL) ATTN: NANCY BUTCHER PHONE NO : 972-728-5534 12740 HILLCREST ROAD, STE 100 SE DECISION MADE: 16-NOV-00 DALLAS, TX 75230 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 ORASURE TECHNOLOGIES, INC. 510(k) NO: K002010(TRADITIONAL) ATTN: R. SAM NIEDBALA PHONE NO : 610-882-1820 1745 EATON AVE SE DECISION MADE: 29-NOV-00 BETHLEHEM, PA 18018-1799 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PCCR DIGITAL IMAGING DEVICE OREX COMPUTED RADIOGRAPHY LTD 510(k) NO: K003256(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN STREET SE DECISION MADE: 08-NOV-00 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K003112(TRADITIONAL) ATTN: SUSAN WERNER PHONE NO : 716-453-4469 100 INDIGO CREEK DRIVE SE DECISION MADE: 02-NOV-00 ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, OSTEOGENICS BIOMEDICAL, INC. 510(k) NO: K003028(TRADITIONAL) ATTN: CHAD BARTEE PHONE NO : 903-677-3950 3234 64TH ST. SE DECISION MADE: 24-NOV-00 LUBBOCK, TX 79413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSALINK TITANIUM ROD-TO-ROD COUPLERS OSTEOTECH, INC. 510(k) NO: K003384(SPECIAL) ATTN: KIM THURMAN PHONE NO : 732-524-2800 51 JAMES WAY SE DECISION MADE: 24-NOV-00 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 PALCO LABS, INC. 510(k) NO: K002787(SPECIAL) ATTN: RICHELLA GOO PHONE NO : 831-461-5677 8030 SOQUEL AVENUE SE DECISION MADE: 29-NOV-00 SANTA CRUZ, CA 95062 510(k) STATEMENT DEVICE: ARAMIS DERMATOLOGICAL LASER PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K002649(TRADITIONAL) ATTN: MARK HELLER PHONE NO : 202-942-8488 131 KELEKENT LANE SE DECISION MADE: 21-NOV-00 CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION PAN BIO INDX, INC. 510(k) NO: K002024(TRADITIONAL) ATTN: DAVID C BISHOP PHONE NO : 610-942-0219 605 DILWORTH ROAD SE DECISION MADE: 22-NOV-00 DOWNINGTOWN, PA 19335 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRECIMED TRAUMA SYSTEM PATRICK BERDOZ 510(k) NO: K002486(TRADITIONAL) ATTN: PATRICK BERDOZ PHONE NO : 610-524-8300 50 DEVYN DRIVE SE DECISION MADE: 09-NOV-00 CHESTER SPRINGS, PA 19425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARELISA TG (THYROGLOBULIN) ANTIBODIES, PHARMACIA & UPJOHN CO. 510(k) NO: K003414(TRADITIONAL) ATTN: KAREN E MATIS PHONE NO : 614-794-3324 5094 ST. ANDREWS DRIVE SE DECISION MADE: 27-NOV-00 WESTERVILLLE, OH 43082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMBOPERITONEAL SHUNT SYSTEM PHOENIX BIOMEDICAL CORP. 510(k) NO: K002476(TRADITIONAL) ATTN: COURTNEY SMITH PHONE NO : 610-539-9300 2495 GENERAL ARMISTEAD AVE. SE DECISION MADE: 09-NOV-00 P.O. BOX 80390 510(k) STATEMENT VALLEY FORGE, PA 19484 DEVICE: 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS PIE MEDICAL 510(k) NO: K002357(TRADITIONAL) ATTN: COLLEEN J HITTLE PHONE NO : 317-849-1916 SE DECISION MADE: 09-NOV-00 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PILLING E-FRAZIER BIPOLAR SUCTION TUBE PILLING 510(k) NO: K002582(TRADITIONAL) ATTN: ELIZABETH LAZARO PHONE NO : 800-523-6507 420 DELAWARE DR. SE DECISION MADE: 03-NOV-00 FORT WASHINGTON, PA 19034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILMAX CONTOUR CARVING BLOCK IMPLANT PILLING SURGICAL 510(k) NO: K002629(TRADITIONAL) ATTN: ROB FRITZENKOTTER PHONE NO : 619-525-7908 P.O. BOX 8141 SE DECISION MADE: 20-NOV-00 LA JOLLA, CA 92038-8141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILMAX PECTORAL IMPLANT PILLING SURGICAL 510(k) NO: K002633(TRADITIONAL) ATTN: ROB FRITZENKOTTER PHONE NO : 800-367-0445 PO BOX 8141 SE DECISION MADE: 21-NOV-00 LA JOLLA, CA 92038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULITPLE MALE LATX CONDOM PLEASURE LATEX PRODUCTS SDN. BHD. 510(k) NO: K002571(ABBREVIATED) ATTN: KOI-YONG LIM PHONE NO : 603 874 0784 LOT 1365, 17TH MILES, JALAN SE DECISION MADE: 16-NOV-00 SUNGAI SEMBILANG 510(k) STATEMENT JERAM, SELANGOR, MALAYSIA 45800 DEVICE: MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET POINTE SCIENTIFIC, INC. 510(k) NO: K002199(TRADITIONAL) ATTN: RON JAMISON PHONE NO : 800-445-9853 1025 JOHN A. PAPALAS DR. SE DECISION MADE: 20-NOV-00 LINCOLN PARK, MI 48146 510(k) STATEMENT DEVICE: SINUSCOPE AND BACCESSORIES POLLUX ENDOSCOPY, INC. 510(k) NO: K002214(TRADITIONAL) ATTN: PRECIOUS J RESCH PHONE NO : 813-719-7397 2404 AIRPORT RD., SUITE 2 SE DECISION MADE: 21-NOV-00 PLANT CITY, FL 33567 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDPOR PTERIONAL SURGICAL IMPLANT POREX SURGICAL PRODUCTS GROUP 510(k) NO: K002586(TRADITIONAL) ATTN: HOWARD MERCER PHONE NO : 678-479-1610 15 DART ROAD SE DECISION MADE: 17-NOV-00 NEWNAN, GA 30265-1017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING PRECISION VASCULAR SYSTEMS, INC. 510(k) NO: K002707(TRADITIONAL) ATTN: JOHN R RAGAZZO PHONE NO : 801-585-7069 360 WAKARA WAY SE DECISION MADE: 08-NOV-00 SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPAQ, MODELS 402 AND 404 PROTOCOL SYSTEMS, INC. 510(k) NO: K002725(TRADITIONAL) ATTN: DON M ABBEY PHONE NO : 503-526-8500 8500 S.W. CREEKSIDE PLACE SE DECISION MADE: 21-NOV-00 BEAVERTON, OR 97008-7107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAYONET FORCEPS BIPOLAR IRRIGATING Q2 MEDICAL 510(k) NO: K002752(TRADITIONAL) ATTN: ERIC MILLS PHONE NO : 502-634-5900 2400 CRITTENDEN DRIVE SE DECISION MADE: 20-NOV-00 LOUISVILLE, KY 40217 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSAIRE DIAGNOSTIC SPIROMETER QRS DIAGNOSTIC, LLC 510(k) NO: K001278(TRADITIONAL) ATTN: JILL R KRALL PHONE NO : 763-559-8560 14755 27TH AVE.NORTH SE DECISION MADE: 29-NOV-00 PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTPACK CONTROL QUALIGEN, INC. 510(k) NO: K003095(ABBREVIATED) ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165 2042 CORTE DEL NOGAL SE DECISION MADE: 29-NOV-00 CARLSBAD, CA 92009-1410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FASTPACK CALIBRATORS QUALIGEN, INC. 510(k) NO: K003096(ABBREVIATED) ATTN: DOROTHY DEINZER PHONE NO : 760-918-9165 2042 CORTE DEL NOGAL SE DECISION MADE: 30-NOV-00 CARLSBAD, CA 92009-1410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYS QUEST INTL., INC. 510(k) NO: K003069(TRADITIONAL) ATTN: ROBERT A CORT PHONE NO : 305-948-8788 1938 N.E. 148TH TERR. SE DECISION MADE: 27-NOV-00 NORTH MIAMI, FL 33181 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R & D 3K RETIC R & D SYSTEMS, INC. 510(k) NO: K003208(SPECIAL) ATTN: KENNETH T EDDS PHONE NO : 612-379-2956 614 MCKINLEY PL., N.E. SE DECISION MADE: 07-NOV-00 MINNEAPOLIS, MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XSCAN32 TELERADIOLOGY SOFTWARE RADIOGRAPHIC DIGITAL IMAGING, INC.510(k) NO: K002911(TRADITIONAL) ATTN: STEPHEN NEUSHUL PHONE NO : 310-639-4920 1215 SOUTH ALAMEDA ST. SE DECISION MADE: 28-NOV-00 COMPTON, CA 90220 510(k) STATEMENT DEVICE: RETINADX REGULATORY ASSOCIATES, INC. 510(k) NO: K003236(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 777 SOUTH WADESWORTH BLVD., SE DECISION MADE: 02-NOV-00 BLDG. 2, SUITE 102 510(k) STATEMENT LAKEWOOD, CO 80226 DEVICE: MICROMANIPULATOR RESEARCH INSTRUMENTS LTD. 510(k) NO: K003142(TRADITIONAL) ATTN: BEN MURDOCK PHONE NO : 44 132 6372753 KERNICK RD. SE DECISION MADE: 22-NOV-00 PENRYN, CORWALL, UNITED KINGDOM TR510(k) STATEMENT DEVICE: RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) RIVERSTONE RESOURCES SDN. BHD. 510(k) NO: K003233(TRADITIONAL) ATTN: CHONG CHU MEE PHONE NO : 603 636 8077 LOT 21909, NO.5, LORONG HELAN SE DECISION MADE: 03-NOV-00 HINDIK KEPONG BARU INDUST. EST 510(k) STATEMENT KEPONG BARU, KUALA LUMPUR, MALAYSIA 52100 DEVICE: CREATININE PLUS ROCHE DIAGNOSTICS CORP. 510(k) NO: K003261(SPECIAL) ATTN: PRISCILLA A HAMILL PHONE NO : 800-428-5074 9115 HAGUE RD. SE DECISION MADE: 16-NOV-00 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROVERS SPATULA ROVERS MEDICAL DEVICES B.V. 510(k) NO: K002520(ABBREVIATED) ATTN: TODD M GATES PHONE NO : 626-744-9171 960 CHAPEA ROAD SE DECISION MADE: 13-NOV-00 PASADENA, CA 91107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAM-PRIME S & C POLYMER GMBH 510(k) NO: K002502(TRADITIONAL) ATTN: JURGEN ENGELBRECHT PHONE NO : 494 121 8619 ROBERT-BOSCH-STR. 5 SE DECISION MADE: 08-NOV-00 D-25335 510(k) SUMMARY AVAILABLE FROM FDA ELMSHORN, GERMANY DEVICE: SALUMEDICA NERVE CUFF SALUMEDICA, L.L.C. 510(k) NO: K002098(TRADITIONAL) ATTN: DAVID N KU PHONE NO : 404-589-1727 112 KROG STREET SE DECISION MADE: 24-NOV-00 SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30307 DEVICE: SAMSUNG 10DR IMPLANT SYSTEM SAMSUNG SDS CO., LTD 510(k) NO: K002062(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-440-9530 2001 EAST OAKSHORES DRIVE SE DECISION MADE: 09-NOV-00 CROSSROADS, TX 76227 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCION CARDIOVASCLAR ANGIOPRO SCION CARIO VASCULAR, INC. 510(k) NO: K001563(TRADITIONAL) ATTN: DAVID B JONES PHONE NO : 915-845-5600 14256 SW 119 AVENUE SE DECISION MADE: 22-NOV-00 MIAMI, FL 33186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGE VASCULAR LASER SCITON, INC. 510(k) NO: K003046(TRADITIONAL) ATTN: PETER ALLEN PHONE NO : 650-493-9155 845 COMMERCIAL AVE. SE DECISION MADE: 24-NOV-00 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H SEIN ELECTRONICS CO., LTD. 510(k) NO: K003282(TRADITIONAL) ATTN: WON KY KIM PHONE NO : 82 31 421 0389 196 ANYANG 7 DONG, MANAN-KU SE DECISION MADE: 01-NOV-00 YOUCHEON FACTOPIA RM. #506 510(k) STATEMENT ANYANG-CITY, KYUNGKI-DO, REPUBLIC OF KOREA 206 DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH A SHANGHAI ANTARES INDUSTRIES, INC. 510(k) NO: K003321(TRADITIONAL) ATTN: JOHN LAI PHONE NO : 011 862 157814213 259 YUSHU RD., SE DECISION MADE: 22-NOV-00 CANGQIAO TOWNSHIP 510(k) STATEMENT SONGJIANG SHANGHAI, CHINA DEVICE: NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON ST SIAM SEMPERMED CORP. LTD. 510(k) NO: K002818(TRADITIONAL) ATTN: WILLIAM HARRIS PHONE NO : 727-787-7250 30798 US HWY 19 NORTH SE DECISION MADE: 29-NOV-00 PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON ST SIAM SEMPERMED CORP. LTD. 510(k) NO: K002819(TRADITIONAL) ATTN: WILLIAM HARRIS PHONE NO : 727-787-7250 30798 US HWY 19 NORTH SE DECISION MADE: 29-NOV-00 PALM HARBOR, FL 34684 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K003179(SPECIAL) ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500 16 ELECTRONICS AVE. SE DECISION MADE: 09-NOV-00 DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLAR SKYTRON, DIV. THE KMW GROUP, INC. 510(k) NO: K002463(TRADITIONAL) ATTN: KARI OGREEN PHONE NO : 616-957-0500 5000 36TH ST S.E. SE DECISION MADE: 08-NOV-00 P.O.BOX 888615 510(k) STATEMENT GRAND RAPIDS, MI 49588-8615 DEVICE: SILENT NIGHT V SLEEP SOLUTIONS, INC. 510(k) NO: K000253(TRADITIONAL) ATTN: CAROLE M SYKES PHONE NO : 650-868-4331 928 LINDEN AVE. SE DECISION MADE: 16-NOV-00 BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL K SMITH & NEPHEW, INC. 510(k) NO: K002740(ABBREVIATED) ATTN: KIM P KELLY PHONE NO : 901-399-6566 1450 E. BROOKS ROAD SE DECISION MADE: 30-NOV-00 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K003399(TRADITIONAL) ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297 21919 30TH DRIVE SE SE DECISION MADE: 16-NOV-00 BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARTAN MTS SPARTAN MARKETING GROUP 510(k) NO: K002521(TRADITIONAL) ATTN: ALDO E EAGLE PHONE NO : 314-343-8300 1663 FENTON BUSINESS PARK CT. SE DECISION MADE: 13-NOV-00 FENTON, MO 63026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIALTY TINT SOFT CONTACT LENS SPECIALTY TINT 510(k) NO: K003079(TRADITIONAL) ATTN: ROBERT BREECE PHONE NO : 540-636-7976 1325 PROGRESS DRIVE SE DECISION MADE: 21-NOV-00 FRONT ROYAL, VA 22630 510(k) STATEMENT DEVICE: MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION SPORICIDIN INTL. 510(k) NO: K003087(TRADITIONAL) ATTN: HAROLD E PLANK PHONE NO : 301-231-7700 121 CONGRESSIONAL LANE SE DECISION MADE: 07-NOV-00 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STI SRS MEDICAL SYSTEMS, INC. 510(k) NO: K002834(TRADITIONAL) ATTN: LEE BRODY PHONE NO : 781-229-1500 14950 N.E. 95TH ST. SE DECISION MADE: 29-NOV-00 REDMOND, WA 98052 510(k) STATEMENT DEVICE: EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 STERITEC PRODUCTS, INC. 510(k) NO: K002861(ABBREVIATED) ATTN: LINDA NELSON PHONE NO : 303-660-4201 599 TOPEKA WAY, SUITE 700 SE DECISION MADE: 29-NOV-00 CASTLE ROCK, CO 80104 510(k) STATEMENT DEVICE: GALAXY STERNGOLD 510(k) NO: K003007(ABBREVIATED) ATTN: SUSAN L SPEAR PHONE NO : 508-226-5660 23 FRANK MOSSBERG DR. SE DECISION MADE: 17-NOV-00 ATTLEBORO, MA 02703-0967 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT STRAUMANN USA 510(k) NO: K002374(TRADITIONAL) ATTN: LINDA JALBERT PHONE NO : 800-448-8168 RESERVOIR PLACE, SE DECISION MADE: 01-NOV-00 1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA WALTHAM, MA 02154 DEVICE: NEWGEN SYSTEM STRYKER INSTRUMENTS 510(k) NO: K002619(TRADITIONAL) ATTN: ROBIN L ROWE PHONE NO : 616-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 16-NOV-00 KALAMAZOO, MI 49001-6197 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 SULTAN CHEMISTS, INC. 510(k) NO: K002843(TRADITIONAL) ATTN: CLARK SMITH PHONE NO : 816-842-2817 124 E. MISSOURI AVE. SE DECISION MADE: 15-NOV-00 KANSAS CITY, MO 64106 510(k) STATEMENT DEVICE: INTER-OP DURASUL ACETABULAR INSERTS (4MM) SULZER ORTHOPEDICS, INC. 510(k) NO: K002575(TRADITIONAL) ATTN: MITCHELL A DHORITY PHONE NO : 512-432-9202 9900 SPECTRUM DRIVE SE DECISION MADE: 15-NOV-00 AUSTIN, TX 78717 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSENSORS CENTRAL VENOUS CATHETER KITS SUNSCOPE INTL., INC. 510(k) NO: K002786(TRADITIONAL) ATTN: JORGE HAIDER PHONE NO : 949-553-8300 20250 ACACIA ST., SUITE 115 SE DECISION MADE: 17-NOV-00 NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGI-VISION PROSTATE COIL SURGI-VISION, INC. 510(k) NO: K002916(TRADITIONAL) ATTN: NANCY E TAYLOR PHONE NO : 410-730-8998 9250 RUMSEY RD., SUITE 100 SE DECISION MADE: 28-NOV-00 COLUMBIA, MD 21045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW SYNTEX U.S.A. INC. 510(k) NO: K002605(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 1690 RUSSELL ROAD SE DECISION MADE: 20-NOV-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLET SYNTHES (USA) 510(k) NO: K002362(TRADITIONAL) ATTN: BONNIE J SMITH PHONE NO : 610-647-9700 P.O. BOX 1766 SE DECISION MADE: 01-NOV-00 1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301-1222 DEVICE: SYNTHES 1.5MM TI BROW LIFT SCREW SYNTHES (USA) 510(k) NO: K002935(TRADITIONAL) ATTN: THOMAS M MAGUIRE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 16-NOV-00 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 35/CD CINECONVERTER TAGARNO A/S 510(k) NO: K001841(TRADITIONAL) ATTN: MAX JENS JENSEN PHONE NO : 457 625 1111 HATTINGVEJ 5 SE DECISION MADE: 15-NOV-00 HORSENS, DENMARK 8700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C. DIFFICILE TOX A/B II TECHLAB, INC. 510(k) NO: K003306(SPECIAL) ATTN: DAVID M LYERLY PHONE NO : 800-832-4522 VPI RESEARCH PARK SE DECISION MADE: 22-NOV-00 1861 PRATT DR. SUITE 1030 510(k) SUMMARY AVAILABLE FROM FDA BLACKSBURG, VA 24060-6364 DEVICE: PINNACLE R/O II OR RADIFOCUS INTRODUCER II TERUMO MEDICAL CORPORATION 510(k) NO: K003424(SPECIAL) ATTN: YUK-TING LEWIS PHONE NO : 410-392-7213 125 BLUE BALL ROAD SE DECISION MADE: 21-NOV-00 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM THE PHANTOM LABORATORY, INC. 510(k) NO: K002840(TRADITIONAL) ATTN: JOSHUA R LEVY PHONE NO : 518-692-1190 2727 STATE ROUTE 29 SE DECISION MADE: 17-NOV-00 GREENWICH, NY 12834 510(k) STATEMENT DEVICE: FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTEN TILLOTSON HEALTHCARE CORPORATION 510(k) NO: K002720(TRADITIONAL) ATTN: F.W. PERRELLA PHONE NO : 603-472-6600 360 ROUTE 101 SE DECISION MADE: 09-NOV-00 BEDFORD, NH 03110-5030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TISSUELINK MONOPOLAR FLOATING BALL' TISSUELINK MEDICAL INC. 510(k) NO: K002680(TRADITIONAL) ATTN: ROBERTA THOMPSON PHONE NO : 603-742-1515 ONE WASHINGTON CENTER SE DECISION MADE: 13-NOV-00 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA DOVER, NH 03820 DEVICE: T.I.M.S., VERSION 2.00 TOTAL MEDICAL INFORMATION MANAGEME510(k) NO: K001947(TRADITIONAL) ATTN: DON BEAVERS PHONE NO : 407-788-6353 407 WEKIVA SPRINGS ROAD SE DECISION MADE: 22-NOV-00 SUITE 301 510(k) SUMMARY AVAILABLE FROM FDA LONGWOOD, FL 32779-6907 DEVICE: TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV TRANSONIC SYSTEMS, INC. 510(k) NO: K002816(TRADITIONAL) ATTN: MARK S ALSBERGE PHONE NO : 607-257-5300 34 DUTCH MILL RD. SE DECISION MADE: 22-NOV-00 WARREN RD. BUSINESS PARK 510(k) SUMMARY AVAILABLE FROM FDA ITHACA, NY 14850 DEVICE: OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYST TRIMEDYNE, INC. 510(k) NO: K001676(TRADITIONAL) ATTN: SUSAN H GAMBLE PHONE NO : 949-559-5300 2801 BARRANCA RD. SE DECISION MADE: 02-NOV-00 P.O. BOX 57001 510(k) SUMMARY AVAILABLE FROM FDA IRVINE, CA 92606 DEVICE: CAPTIA SYPHILIS-G ELISA TEST SYSTEM TRINITY BIOTECH, PLC 510(k) NO: K001525(TRADITIONAL) ATTN: WAYNE KVETKOSKY PHONE NO : 716-483-3851 PO BOX 1059, 2823 GIRTS ROAD SE DECISION MADE: 29-NOV-00 JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MO VASCULAR TECHNOLOGY, INC. 510(k) NO: K002990(TRADITIONAL) ATTN: DAVID L REGAN PHONE NO : 978-453-1055 175 CABOT ST. SE DECISION MADE: 06-NOV-00 LOWELL, MA 01854 510(k) STATEMENT DEVICE: VIATRONIX VISUALIZATION SYSTEM (VVS) VIATRONIX INC. 510(k) NO: K002780(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD. SE DECISION MADE: 17-NOV-00 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: TISSUE SPECTROSCOPE VITAL MEDICAL LTD. 510(k) NO: K992529(TRADITIONAL) ATTN: BRUCE F MACKLER PHONE NO : 202-263-8900 815 CONNECTICUT AVE., N.W. SE DECISION MADE: 17-NOV-00 WASHINGTON, DC 20006-4004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLOBOND PLUS VOCO GMBH 510(k) NO: K003153(TRADITIONAL) ATTN: EVAN DICK PHONE NO : 314-721-0112 7527 WESTMORELAND AVE. SE DECISION MADE: 15-NOV-00 ST. LOUIS, MO 63105 510(k) STATEMENT DEVICE: COD COMPRESSION OSTEOTOMY DEVICE WALTER ABENDSCHEIN, M.D. 510(k) NO: K002184(TRADITIONAL) ATTN: WALTER ABENDSCHEIN PHONE NO : 301-656-4317 5530 WISCONSIN AVENUE SE DECISION MADE: 24-NOV-00 SUITE 705 510(k) SUMMARY AVAILABLE FROM FDA CHEVY CHASE, MD 20815 DEVICE: WARTNER WART REMOVAL SYSTEM WARTNER MEDICAL PRODUCTS 510(k) NO: K002714(TRADITIONAL) ATTN: JUDY MAGNER PHONE NO : 905 794 3339 25 BELLINI AVE. SE DECISION MADE: 28-NOV-00 BRAMPTON, ONTARIO, CANADA L6T 3Z8 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELCH ALLYN SPOT CHECK DEVICE WELCH ALLYN, INC. 510(k) NO: K002530(ABBREVIATED) ATTN: JOSEPH D BUCHANAN PHONE NO : 828-684-4895 95 OLD SHOALS RD. SE DECISION MADE: 14-NOV-00 ARDEN, NC 28704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIRST CHECK HOME DRUG TEST PANEL 4 WORLDWIDE MEDICAL CORPORATION 510(k) NO: K993852(TRADITIONAL) ATTN: LARRY R PILOT PHONE NO : 202-496-7561 1900 K STREET NW SE DECISION MADE: 29-NOV-00 WASHINGTON, DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WMT ULTRA-FIT MODULAR SHOULDER SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K002683(TRADITIONAL) ATTN: EHAB M ESMAIL PHONE NO : 901-867-4732 5677 AIRLINE RD. SE DECISION MADE: 22-NOV-00 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (T WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K001613(TRADITIONAL) ATTN: YUE WHA CHOW PHONE NO : 60 387 061486 LOT 1, JALAN 3, SE DECISION MADE: 22-NOV-00 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, N WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K002064(TRADITIONAL) ATTN: YUE WAH CHOW PHONE NO : 603 870 61486 LOT 1, JALAN 3, SE DECISION MADE: 28-NOV-00 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STER WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K003019(TRADITIONAL) ATTN: YUE WAH CHOW PHONE NO : 011 603 87061486 LOT 1, JALAN 3, SE DECISION MADE: 03-NOV-00 KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900 DEVICE: DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOV WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K003132(TRADITIONAL) ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 603 387 069788 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 17-NOV-00 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOV WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K003307(TRADITIONAL) ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 60 3 87069788 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 22-NOV-00 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CO WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K003309(TRADITIONAL) ATTN: MOHD HAIZAN HUSSEIN PHONE NO : 60 3 87069788 LOT11, JL.2,KAWASAN PERUSAHAAN SE DECISION MADE: 22-NOV-00 BANDAR BARU SLAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA SELANGOR DAURL EHSAN, SEPANG, MALAYSIA 43900 DEVICE: MINITUB MULTI-PURPOSE CASSETTES ZANDER MEDICAL SUPPLIES, INC. 510(k) NO: K002961(TRADITIONAL) ATTN: FRIEDEL MW ZANDER PHONE NO : 561-569-5955 755 8TH CT., SUITE #4 SE DECISION MADE: 21-NOV-00 P.O.650790 510(k) SUMMARY AVAILABLE FROM FDA VERO BEACH, FL 32965-0790 DEVICE: RS BIOTECH GALAXY 'R' CO2 INCUBATOR ZANDER MEDICAL SUPPLIES, INC. 510(k) NO: K003184(TRADITIONAL) ATTN: FRIEDEL MW ZANDER PHONE NO : 561-569-5955 755 8TH CT., SUITE #4 SE DECISION MADE: 20-NOV-00 P.O.650790 510(k) SUMMARY AVAILABLE FROM FDA VERO BEACH, FL 32965-0790 DEVICE: ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3- ZYNERGY CARDIOVASCULAR, INC. 510(k) NO: K002687(TRADITIONAL) ATTN: JING ZHANG PHONE NO : 732-225-3800 298 FERNWOOD AVENUE SE DECISION MADE: 09-NOV-00 EDISON, NJ 08837-3839 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 270 TOTAL WITH SUMMARIES 205 TOTAL WITH STATEMENTS 65
Updated 4/30/2001
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