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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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