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510(k)s Final Decisions Rendered for October 2002 |
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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-OCT-2002 THROUGH 31-OCT-2002
DEVICE: OCO DENTAL IMPLANT (5.0MM DIAMETER)
"O" CO., INC. 510(k) NO: K023336(SPECIAL)
ATTN: DAVID D DALISE PHONE NO : 505-293-0025
600 PAISANO, N.E., SUITE A SE DECISION MADE: 09-OCT-02
ALBUQUERQUE, NM 87123 510(k) STATEMENT
DEVICE: SENSUA!
AAC CONSULTING GROUP, INC. 510(k) NO: K021125(TRADITIONAL)
ATTN: EDUARDO MARCH PHONE NO : 301-838-3120
7361 CALHOUN PL.#500 SE DECISION MADE: 25-OCT-02
ROCKVILLE, MD 20855-2774 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOO
ABBOTT LABORATORIES 510(k) NO: K022941(TRADITIONAL)
ATTN: JOSEPH MAGLIOZZI PHONE NO : 781-276-6293
4-A CROSBY DR. SE DECISION MADE: 28-OCT-02
BEDFORD, MA 01730-1402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTA
ACON LABORATORIES, INC. 510(k) NO: K022589(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 28-OCT-02
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSV12 SOFTWARE VIEWER
ACUSON CORP. 510(k) NO: K022896(SPECIAL)
ATTN: BOB LEIKER PHONE NO : 650-694-5080
1220 CHARLESTON RD. SE DECISION MADE: 03-OCT-02
MOUNTAIN VIEW, CA 94039-7393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPE
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K022441(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6482
33 TECHNOLOGY DR. SE DECISION MADE: 08-OCT-02
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED USED, DISPOSABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHET
ADVEN MEDICAL 510(k) NO: K012674(TRADITIONAL)
ATTN: MARK W ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY. SE DECISION MADE: 31-OCT-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNIFF POSITION PILLOWS/POPITZ PILLOWS
AEOLUS INTERNATIONAL CORPORATION 510(k) NO: K023010(ABBREVIATED)
ATTN: MICHAEL D POPITZ PHONE NO : 617-435-1016
64 INDIAN COVE RD. SE DECISION MADE: 01-OCT-02
MARION, MA 02738-2113 510(k) STATEMENT
DEVICE: CRANIOCUT
AESCULAP, INC. 510(k) NO: K022942(TRADITIONAL)
ATTN: GEORG KELLER PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 21-OCT-02
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AART SILICONE TUBING
AESTHETIC AND RECONSTRUCTIVE TECHN510(k) NO: K022306(TRADITIONAL)
ATTN: CATHERINE RIPLE PHONE NO : 805-239-1059
5871 LONE PINE PLACE SE DECISION MADE: 10-OCT-02
PASO ROBLES, CA 93446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRYSTAR 5500
AGFA CORP. 510(k) NO: K023287(SPECIAL)
ATTN: JEFF JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST. SE DECISION MADE: 22-OCT-02
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
ALCON LABORATORIES, INC. 510(k) NO: K023249(ABBREVIATED)
ATTN: CHRISTY STEVENS PHONE NO : 407-384-1648
2501 DISCOVERY DRIVE,SUITE 500 SE DECISION MADE: 18-OCT-02
ORLANDO, FL 32826-3714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K022765(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 11-OCT-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATHABLE SURGICAL GOWN
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K023167(SPECIAL)
ATTN: SHARON NICHOLS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 02-OCT-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES
ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K023170(SPECIAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 09-OCT-02
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMX DISPOSABLE BAG MASK RESUSCITATOR
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K014071(TRADITIONAL)
ATTN: VERNON TRIMBLE PHONE NO : 314-771-2400
1720 SUBLETTE AVE. SE DECISION MADE: 01-OCT-02
ST. LOUIS, MO 63110 510(k) STATEMENT
DEVICE: ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, CO
ALTUS MEDICAL, INC. 510(k) NO: K022226(TRADITIONAL)
ATTN: KATHY MAYNOR PHONE NO : 650-552-9700
821 COWAN RD. SE DECISION MADE: 08-OCT-02
BURLINGAME, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEW OUTLINE
ANAXDENT GMBH 510(k) NO: K023079(TRADITIONAL)
ATTN: DVORAH RICHMAN PHONE NO : 202-626-2948
1730 PENNSYLVANIA N.W. SE DECISION MADE: 30-OCT-02
WASHINGTON, DC 20006 510(k) STATEMENT
DEVICE: BIOLOGICAL SOUND MONITOR (BSM) SENSOR
ANDROMED, INC. 510(k) NO: K021389(ABBREVIATED)
ATTN: GENEVIEVE HAMEL PHONE NO : 514 336 0043
4610 BOIS-FRANC ROAD SE DECISION MADE: 01-OCT-02
SAINT-LAURENT, QUEBEC, CANADA H4S 510(k) STATEMENT
DEVICE: I-STETHOS LINK
ANDROMED, INC. 510(k) NO: K022298(ABBREVIATED)
ATTN: GENEVIEVE HAMEL PHONE NO : 514 336 0043
4610 BOIS-FRANC ROAD SE DECISION MADE: 01-OCT-02
SAINT LAURENT, QUEBEC, CANADA H45 510(k) STATEMENT
DEVICE: EZ-SCOPE AN, EZ-SCOPE LIGHT
ANZAI MEDICAL CO, LTD. 510(k) NO: K022342(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE ROAD SE DECISION MADE: 09-OCT-02
BROOKEVILLE, MD 20833-2233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUCATH.IP
AORTECH CRITICAL CARE LTD. 510(k) NO: K023368(TRADITIONAL)
ATTN: PAUL BURNS PHONE NO : 00 44 1698746699
PHOENIX CRESCENT SE DECISION MADE: 28-OCT-02
STRATHCLYDE BUSINESS PARK 510(k) STATEMENT
BELLSHILL, LANARKSHIRE, UNITED KINGDOM ML4 3NJ
DEVICE: DRUGFREE@HOME THC TEST
APPLIED BIOTECH, INC. 510(k) NO: K022802(TRADITIONAL)
ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483
17394 VIA DEL BRAVO SE DECISION MADE: 16-OCT-02
P.O. BOX 9433 510(k) SUMMARY AVAILABLE FROM FDA
RANCHO SANTA FE,, CA 92067
DEVICE: DRUGFREE@HOME COCAINE TEST
APPLIED BIOTECH, INC. 510(k) NO: K022805(TRADITIONAL)
ATTN: VIVIANNE NOETZEL PHONE NO : 858-756-8483
17394 VIA DEL BRAVO SE DECISION MADE: 16-OCT-02
P.O. BOX 9433 510(k) SUMMARY AVAILABLE FROM FDA
RANCHO SANTA FE,, CA 92067
DEVICE: PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S
ARC MEDICAL SUPPLIES (BEIJING) CO,510(k) NO: K022666(TRADITIONAL)
ATTN: CHARLES F ANDREWS PHONE NO : 414-416-9119
1591 S. MOORLAND ROAD SE DECISION MADE: 09-OCT-02
SUITE 104 510(k) SUMMARY AVAILABLE FROM FDA
NEW BERLIN, WI 53151
DEVICE: LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF
ARISTA LATINDO INDUSTRIAL, LTD. P.510(k) NO: K022987(TRADITIONAL)
ATTN: LINGA SUMARTA PHONE NO : 62 21 6620201
JL: K.H.MOH MANSYUR NO. 128 SE DECISION MADE: 21-OCT-02
JAKARTA, INDONESIA 11210 510(k) STATEMENT
DEVICE: ARTERIA OCCLUSION BALLOON
ARTERIA MEDICAL SCIENCE, INC. 510(k) NO: K021210(TRADITIONAL)
ATTN: ALAN HINTON PHONE NO : 707-422-1778
22 HILL ST. SE DECISION MADE: 28-OCT-02
NEWBURYPORT, MA 01950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
ARTHREX, INC. 510(k) NO: K022234(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 03-OCT-02
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), AR
ARTHROCARE CORP. 510(k) NO: K022475(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 03-OCT-02
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
ASEPTICO, INC. 510(k) NO: K022217(TRADITIONAL)
ATTN: GRANT RAMALEY PHONE NO : 425-487-3157
8333 216TH ST., S.E. SE DECISION MADE: 24-OCT-02
WOODINVILLE, WA 98072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K023285(TRADITIONAL)
ATTN: EILEEN MCCAFFERTY PHONE NO : 441 382 422000
THE TECHNOLOGY PARK SE DECISION MADE: 09-OCT-02
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) STATEMENT
DEVICE: EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WO
AXON SYSTEMS, INC. 510(k) NO: K022785(SPECIAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112
400-2200 OSER AVE. SE DECISION MADE: 09-OCT-02
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
AXYA MEDICAL, INC. 510(k) NO: K022207(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
100 CUMMINGS CENTER SE DECISION MADE: 04-OCT-02
SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: REUSABLE BRONCHIAL BIOPSY FORCEPS
BALLARD MEDICAL PRODUCTS 510(k) NO: K022398(TRADITIONAL)
ATTN: CINDY ELLIS PHONE NO : 801-523-5207
12050 LONE PEAK PKWY. SE DECISION MADE: 11-OCT-02
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K020807(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 01-OCT-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
BAYER DIAGNOSTICS CORP. 510(k) NO: K022668(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE SE DECISION MADE: 15-OCT-02
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON LX I 725 CLINICAL SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K023049(SPECIAL)
ATTN: MARY BETH TANG PHONE NO : 714-961-3777
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 04-OCT-02
BREA, CA 92822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
BECTON DICKINSON & CO. 510(k) NO: K022580(TRADITIONAL)
ATTN: PETER ZURLO PHONE NO : 201-847-6447
1 BECTON DRIVE SE DECISION MADE: 09-OCT-02
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM
BECTON DICKINSON & CO. 510(k) NO: K022581(TRADITIONAL)
ATTN: JOHN SCHALAGO PHONE NO : 201-847-5663
1 BECTON DRIVE SE DECISION MADE: 09-OCT-02
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
BECTON DICKINSON & CO. 510(k) NO: K022637(TRADITIONAL)
ATTN: EILEEN T SCHWEIGHARDT PHONE NO : 201-847-4570
1 BECTON DRIVE SE DECISION MADE: 16-OCT-02
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD K-4000 MICROKERATOME SYSTEM
BECTON DICKINSON & CO. 510(k) NO: K023092(SPECIAL)
ATTN: EILEEN T SCHWEIGHARDT PHONE NO : 201-847-4570
1 BECTON DRIVE SE DECISION MADE: 18-OCT-02
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16
BECTON, DICKINSON AND COMPANY 510(k) NO: K023273(TRADITIONAL)
ATTN: KATHRYN BABKA POWERS PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 31-OCT-02
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLEEVA FABRIC
BIO MED SCIENCES, INC. 510(k) NO: K023136(SPECIAL)
ATTN: MARK E DILLON PHONE NO : 610-432-8220
1111 W. HAMILTON ST. SE DECISION MADE: 16-OCT-02
ALLENTOWN, PA 18101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSTEON CROSS PIN
BIOCOMPOSITES LTD. 510(k) NO: K021351(TRADITIONAL)
ATTN: J. STEPHEN BRATT PHONE NO : 441 782 206500
ETRUSCAN ST., ETRURIA SE DECISION MADE: 17-OCT-02
STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTAPLE
BIOMEDICAL ENT., INC. 510(k) NO: K023203(SPECIAL)
ATTN: W. CASEY FOX PHONE NO : 210-677-0354
14785 OMICRON DR., SUITE 205 SE DECISION MADE: 17-OCT-02
SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTAPLE, MAXILLOFACIAL
BIOMEDICAL ENTERPRISES, INC 510(k) NO: K023486(SPECIAL)
ATTN: W. CASEY FOX PHONE NO : 210-677-0354
14785 OMICRON DR STE 205 SE DECISION MADE: 31-OCT-02
SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTAPLE, CRANIOFACIAL
BIOMEDICAL ENTERPRISES, INC 510(k) NO: K023488(SPECIAL)
ATTN: W. CASEY FOX PHONE NO : 210-677-0354
14785 OMICRON DR STE 205 SE DECISION MADE: 31-OCT-02
SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
BIOMERIEUX, INC. 510(k) NO: K020810(TRADITIONAL)
ATTN: SANDRA PERREAND PHONE NO : 314-731-8594
595 ANGLUM RD. SE DECISION MADE: 03-OCT-02
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINGLOC CONSTRAINED LINERS
BIOMET ORTHOPEDICS, INC. 510(k) NO: K021661(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
P.O. BOX 587 SE DECISION MADE: 25-OCT-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
BIOMET ORTHOPEDICS, INC. 510(k) NO: K023085(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 17-OCT-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINGLOC CONSTRAINED LINERS II
BIOMET, INC. 510(k) NO: K021728(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 219-267-6639
56 EAST BELL DR. SE DECISION MADE: 25-OCT-02
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUGEN FX SCREW
BIONX IMPLANTS, INC. 510(k) NO: K023022(SPECIAL)
ATTN: GERARD S CARLOZZI PHONE NO : 215-643-5000
1777 SENTRY PKWY. WEST, SE DECISION MADE: 04-OCT-02
GWYNEDD HALL, SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
BLUE BELL, PA 19422
DEVICE: LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL -
BIORESOURCE TECHNOLOGY, INC. 510(k) NO: K023032(TRADITIONAL)
ATTN: ALAN POSNER PHONE NO : 954-792-5222
1531 N.W. 65TH AVE. SE DECISION MADE: 08-OCT-02
FORT LAUDERDALE, FL 33313-4542 510(k) STATEMENT
DEVICE: AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
BIOTRONIK, INC. 510(k) NO: K023099(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 18-OCT-02
LAKE OSWEGO, OR 97035-5369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOVER
BIOVER AG 510(k) NO: K011208(TRADITIONAL)
ATTN: HEINZ E WICK PHONE NO : 610-521-4073
252 W. RIDLEY AVENUE SE DECISION MADE: 02-OCT-02
RIDLEY PARK, PA 19078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS 400
BODY CLOCK HEALTH CARE LTD 510(k) NO: K022493(TRADITIONAL)
ATTN: JONATHAN BASH PHONE NO : 440 208 5329595
108 GEORGE LANE SE DECISION MADE: 11-OCT-02
SOUTH WOODFORD, LONDON, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K021630(TRADITIONAL)
ATTN: TODD KORNMANN PHONE NO : 800-553-5878
ONE SCIMED PLACE SE DECISION MADE: 25-OCT-02
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
BOSTON SCIENTIFIC CORP. 510(k) NO: K023291(SPECIAL)
ATTN: ANDREA L RUTH PHONE NO : 408-985-3608
2710 ORCHARD PARKWAY SE DECISION MADE: 17-OCT-02
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GU
BOSTON SCIENTIFIC, TARGET 510(k) NO: K022357(TRADITIONAL)
ATTN: GEORGE J PRENDERGAST PHONE NO : 510-440-7604
47900 BAYSIDE PARKWAY SE DECISION MADE: 16-OCT-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VECTORVISION CT-FREE KNEE
BRAINLAB AG 510(k) NO: K021306(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 25-OCT-02
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
BRENNEN MEDICAL, INC. 510(k) NO: K021835(TRADITIONAL)
ATTN: PHILLIP B LAWIN PHONE NO : 651-429-7413
1290 HAMMOND RD. SE DECISION MADE: 17-OCT-02
ST. PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA SMOOTHBEAM LASER SYSTEM
CANDELA CORP. 510(k) NO: K014128(TRADITIONAL)
ATTN: LORRAINE NELSON PHONE NO : 508-358-7637
530 BOSTON POST RD. SE DECISION MADE: 04-OCT-02
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
CANON, INC. 510(k) NO: K023124(TRADITIONAL)
ATTN: SHIELA DRISCOLL PHONE NO : 516 328 5602
30-2 SHIMOMARUKO 3-CHOME SE DECISION MADE: 04-OCT-02
OHTA-KU, TOKYO, JAPAN, JAPAN 146 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SP
CANTOR & NISSEL LTD. 510(k) NO: K022373(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 07-OCT-02
GRAND JUCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
CARDIAC SCIENCE, INC. 510(k) NO: K022210(TRADITIONAL)
ATTN: JOHN CARLINE PHONE NO : 952-939-4181
16931 MILLIKAN AVE. SE DECISION MADE: 04-OCT-02
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARRAKLENZ AND ULTRAKLENZ
CARRINGTON LABORATORIES, INC. 510(k) NO: K022670(TRADITIONAL)
ATTN: MARY MC-NAMARA-CULINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 17-OCT-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDARA I-SOFTVIEW
CEDARA SOFTWARE CORP. 510(k) NO: K022881(TRADITIONAL)
ATTN: CAROL NAKAGAWA PHONE NO : 905 672 2100
6509 AIRPORT RD. SE DECISION MADE: 22-OCT-02
MISSISSAUGA, ONTARIO, CANADA L4V 1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
CENTERPULSE SPINE-TECH, INC. 510(k) NO: K022615(SPECIAL)
ATTN: ANGELA BYLAND PHONE NO : 952-857-5631
7375 BUSH LAKE ROAD SE DECISION MADE: 29-OCT-02
MINNEAPOLIS, MN 55439-3037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMX COMPACT RESUCITATOR
CHEEN HOUNG ENT. CO. LTD. 510(k) NO: K021390(TRADITIONAL)
ATTN: JAY WANG PHONE NO : 886 226 892001
23 SAN DREEN ST., ALLEY 11, SE DECISION MADE: 04-OCT-02
LANE 65 510(k) STATEMENT
TAIPEI (SHULIN), CHINA (TAIWAN) 23805
DEVICE: INFUSION CATHETER EXTENSION SET
CHF SOLUTIONS, INC. 510(k) NO: K023224(SPECIAL)
ATTN: AMY PETERSON PHONE NO : 763-463-4620
SUITE 170-7601 NORTHLAND DRIVE SE DECISION MADE: 25-OCT-02
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARATS MULTIPURPOSE SOLUTION
CIBA VISION CORP. 510(k) NO: K021635(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678-415-3897
11460 JOHNS CREEK PKWY. SE DECISION MADE: 28-OCT-02
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BEC
CLINIQA CORPORATION 510(k) NO: K022867(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 02-OCT-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN C
CLINIQA CORPORATION 510(k) NO: K022885(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 800-728-5205
1432 SOUTH MISSION ROAD SE DECISION MADE: 02-OCT-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULT
CLINIQA CORPORATION 510(k) NO: K022936(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-728-5205
1432 SOUTH MISSION ROAD SE DECISION MADE: 02-OCT-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKM
CLINIQA CORPORATION 510(k) NO: K023250(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION ROAD SE DECISION MADE: 17-OCT-02
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CMA CEREBRAL TISSUE MONITORING SYSTEM
CMA MICRODIALYSIS AB 510(k) NO: K020285(TRADITIONAL)
ATTN: SHEILA HEMEON-HEYER PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 23-OCT-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X
COLOPLAST CORP. 510(k) NO: K013525(TRADITIONAL)
ATTN: HARVEY M ARBIT PHONE NO : 507-345-6200
1940 COMMERCE DR. SE DECISION MADE: 04-OCT-02
NORTH MANKATO, MN 56003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMFORT DREAMRIDER SCOOTER, LY-EW402
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K021910(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO 58 FU-CHIUN ST. SE DECISION MADE: 11-OCT-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: COMFORT WINDJOY SCOOTER, MODEL LY-EW302
COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K022369(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58,FU-CHIUN ST. SE DECISION MADE: 11-OCT-02
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
COMPUTER MOTION, INC. 510(k) NO: K022897(SPECIAL)
ATTN: CATHY STUPAK PHONE NO : 805-685-3729
130 CREMONA DRIVE, SUITE B SE DECISION MADE: 11-OCT-02
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOCUS RADIATION TREATMENT PLANNING SYSTEM
COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K020027(TRADITIONAL)
ATTN: MICHAEL A PARSONS PHONE NO : 314-993-0003
1145 CORPORATE LAKE DR. SE DECISION MADE: 08-OCT-02
ST. LOUIS, MO 63132-1716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDO
CONDOMI ERFERT PRODOKTIONSGESELLSC510(k) NO: K021186(TRADITIONAL)
ATTN: CAROLANN KOTULA PHONE NO : 516-482-9001
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 25-OCT-02
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODENT DENTAL LASER SYSTEM
CONTINUUM ELECTRO-OPTICS, INC. 510(k) NO: K022351(TRADITIONAL)
ATTN: THOMAS J HANEY PHONE NO : 408-727-3240
3150 CENTRAL EXPRESSWAY SE DECISION MADE: 16-OCT-02
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK INJECTION NEEDLE
COOK UROLOGICAL, INC. 510(k) NO: K022484(TRADITIONAL)
ATTN: DEBBIE SCHMITT PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 25-OCT-02
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466
CORDIS CORP. 510(k) NO: K023116(SPECIAL)
ATTN: KAREN WILK PHONE NO : 908-412-7446
7 POWDER HORN DR. SE DECISION MADE: 18-OCT-02
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY
CORDIS CORP. 510(k) NO: K023217(SPECIAL)
ATTN: SAM MIRZA PHONE NO : 305-824-2007
14201 N.W. 60TH AVE. SE DECISION MADE: 25-OCT-02
MIAMI LAKES, FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAXX ELECTRIC WHEELCHAIR
CROSSROADS DISTRIBUTION COMPANY, L510(k) NO: K022194(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 29-OCT-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: DFV CPG COLPOSCOPE
D.F. VASCONCELLOS S.A. 510(k) NO: K021854(TRADITIONAL)
ATTN: JEAN M BUCHWALD PHONE NO : 305-957-7875
1990 NE 163 RD STREET SE DECISION MADE: 25-OCT-02
SUITE 107 510(k) SUMMARY AVAILABLE FROM FDA
NORTH MIAMI, FL 33162
DEVICE: MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFPODOXIME
DADE MICROSCAN, INC. 510(k) NO: K023202(SPECIAL)
ATTN: CYNTHIA VAN DUKER PHONE NO : 916-374-3105
1584 ENTERPRISE BLVD. SE DECISION MADE: 23-OCT-02
WEST SACRAMENTO, CA 95691 510(k) STATEMENT
DEVICE: DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-
DATEX-OHMEDA 510(k) NO: K022485(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 03-OCT-02
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900
DATEX-OHMEDA, INC. 510(k) NO: K021955(SPECIAL)
ATTN: MICHAEL A CHILBERT PHONE NO : 303-666-7001
1315 WEST CENTURY DR. SE DECISION MADE: 08-OCT-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX,
DENTAL VIPI LTDA 510(k) NO: K022300(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 03-OCT-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: DIASOL-ADDITIVES
DIASOL, INC. 510(k) NO: K020231(TRADITIONAL)
ATTN: MONICA ABELES PHONE NO : 818-255-1800
13212 RAYMER ST. SE DECISION MADE: 21-OCT-02
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEG
DIDECO S.P.A. 510(k) NO: K022450(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST STREET SE DECISION MADE: 22-OCT-02
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K023471(SPECIAL)
ATTN: DAVID E CHADWICK PHONE NO : 763-795-5277
5151 PROGRAM AVENUE SE DECISION MADE: 29-OCT-02
ST. PAUL, MN 55112-1014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDI
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K020339(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 25-OCT-02
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
DYNAREX CORP. 510(k) NO: K012816(TRADITIONAL)
ATTN: JOHN GAGLIARDI PHONE NO : 513-573-0085
7736 WOODSIDE COURT SE DECISION MADE: 17-OCT-02
MAINEVILLE, OH 45039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
EBI, L.P. 510(k) NO: K023133(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 18-OCT-02
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
EBI, L.P. 510(k) NO: K023204(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 18-OCT-02
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K023324(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 18-OCT-02
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI XFIX DFS SYSTEM
EBI, L.P. 510(k) NO: K023399(SPECIAL)
ATTN: FREDERIC TESTA PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 25-OCT-02
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH 1
EMED, INC. 510(k) NO: K022583(TRADITIONAL)
ATTN: KENNETH KARASIUK PHONE NO : 805-446-2200
191 WEST WILBUR ROAD SE DECISION MADE: 31-OCT-02
SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA
THOUSAND OAKS, CA 91360
DEVICE: ENDIUS ATAVI SYSTEM
ENDIUS, INC. 510(k) NO: K022199(TRADITIONAL)
ATTN: CHRISTINE KUNTZ NASSIF PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 02-OCT-02
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS T
EPOR, INC. 510(k) NO: K022665(TRADITIONAL)
ATTN: ERIC V HOHENSTEIN PHONE NO : 323-549-3831
731 1/2 NORTH LABREA AVE. SE DECISION MADE: 09-OCT-02
LOS ANGELES, CA 90038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELIX HYDRO-JET
ERBE USA, INC. 510(k) NO: K022613(TRADITIONAL)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400
2225 NORTHWEST PKWY., SE DECISION MADE: 25-OCT-02
MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCU
ERECORDS LIMITED 510(k) NO: K021087(ABBREVIATED)
ATTN: ED GOSS PHONE NO : 416 383 0046
801 YORK MILLS ROAD SE DECISION MADE: 11-OCT-02
SUITE 314 510(k) SUMMARY AVAILABLE FROM FDA
TORONTO, CANADA M3B 1X7
DEVICE: INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH,
ETHICON ENDO-SURGERY, INC. 510(k) NO: K023182(SPECIAL)
ATTN: CAROL SPRINKLE PHONE NO : 513-337-3792
4545 CREEK RD. SE DECISION MADE: 24-OCT-02
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K020749(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 31-OCT-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
EVERYWAY MEDICAL INSTRUMENTS CO., 510(k) NO: K020750(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 31-OCT-02
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
EXACTECH, INC. 510(k) NO: K023186(SPECIAL)
ATTN: MARTIN SPRUNCH PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 17-OCT-02
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROFIX
FIXANO SA 510(k) NO: K023314(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 858-587-1147
P.O BOX 12038 SE DECISION MADE: 18-OCT-02
LA JOLLA, CA 92039-2038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864,
FORTUNE MEDICAL INSTRUMENT CORP. 510(k) NO: K021142(TRADITIONAL)
ATTN: TYLER WANG PHONE NO : 886 2 26360488
12-9, LIN 5, MAO-CHANG VILLAGE SE DECISION MADE: 01-OCT-02
SAN-CHIH HSIANG 510(k) STATEMENT
TAIPEI HSIEN, CHINA (TAIWAN)
DEVICE: \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE
FRESENIUS MEDICAL CARE 510(k) NO: K022536(TRADITIONAL)
ATTN: ART EILINSFELD PHONE NO : 781-402-9068
95 HAYDEN AVE SE DECISION MADE: 30-OCT-02
LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRYE ADJUSTING INSTRUMENT
FRYE HEALTH SYSTEMS 510(k) NO: K021238(TRADITIONAL)
ATTN: DEBORAH F KONENMAN PHONE NO : 602-418-6483
2751 E. HALE STREET SE DECISION MADE: 09-OCT-02
MESA, AZ 85213 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLASSIC GREAT TOE IMPLANT
FUTURA BIOMEDICAL 510(k) NO: K023086(SPECIAL)
ATTN: LOUISE M FOCHT PHONE NO : 760-599-1670
990 PARK CENTER DR., SUITE H SE DECISION MADE: 04-OCT-02
VISTA, CA 92083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1CC FUTURA SAFETY SYRINGE
FUTURA MEDICAL TECHNOLOGY 510(k) NO: K023323(SPECIAL)
ATTN: DAVID OLMSTEAD PHONE NO : 909-946-5280
380 STEVENS AVE., SUITE 212 SE DECISION MADE: 29-OCT-02
SOLANA BEACH, CA 92075 510(k) STATEMENT
DEVICE: GALEMED NEB-EASY NEBULIZER
GALEMED CORP. 510(k) NO: K021742(TRADITIONAL)
ATTN: TOM SHANKS PHONE NO : 909-506-2674
29201 VIA NORTE SE DECISION MADE: 25-OCT-02
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISO FUNCTIONAL
GC AMERICA, INC. 510(k) NO: K022430(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 18-OCT-02
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: E-SPEED EBT SCANNER SYSTEM
GE IMATRON 510(k) NO: K022794(TRADITIONAL)
ATTN: KERRY A SPEAR PHONE NO : 650-742-8801
389 OYSTER POINT BLVD. SE DECISION MADE: 11-OCT-02
SOUTH SAN FRANSISCO, CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
GE MEDICAL SYSTEMS 510(k) NO: K023332(SPECIAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 23-OCT-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNOVA AND INNOVA 2000 S
GE MEDICAL SYSTEMS, INC. 510(k) NO: K022322(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 414-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 08-OCT-02
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY NETWORK ID
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K021454(TRADITIONAL)
ATTN: JOELLE NEIDER PHONE NO : 203-949-8232
8200 WEST TOWER AVE. SE DECISION MADE: 01-OCT-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMP
GENERAL ELECTRIC MEDICAL SYSTEMS I510(k) NO: K023100(SPECIAL)
ATTN: LISA LEE MICHELS PHONE NO : 262-293-1609
8200 WEST TOWER AVE. SE DECISION MADE: 11-OCT-02
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GETTIG DISPOSABLE SYRINGES
GETTIG PHARMACEUTICAL INSTRUMENT C510(k) NO: K022495(TRADITIONAL)
ATTN: JAMES A BENZ PHONE NO : 814-422-8892
ONE STREAMSIDE PL. WEST SE DECISION MADE: 08-OCT-02
SPRING MILLS, PA 16875-0085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS
GUIDANT CORP. 510(k) NO: K023300(SPECIAL)
ATTN: JANELL A COLLEY PHONE NO : 651-582-6691
4100 HAMLINE AVE., NORTH SE DECISION MADE: 28-OCT-02
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS ENT NERVE STIMULATOR
GYRUS ENT L.L.C. 510(k) NO: K021595(TRADITIONAL)
ATTN: GREG SREDIN PHONE NO : 901-373-0200
2925 APPLING RD SE DECISION MADE: 24-OCT-02
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012
HANDPIECE UNLIMITED 510(k) NO: K021250(TRADITIONAL)
ATTN: MARTINA GUNDEROTH PHONE NO : 494 513 882860
KATHARINENSTR. 5 SE DECISION MADE: 24-OCT-02
LUBECK, GERMANY 23554 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUILLA MODULAR WHEELCHAIR
HAYWOOD VOCATIONAL OPPORTUNITIES 510(k) NO: K023005(TRADITIONAL)
ATTN: RICHARD O WOOD PHONE NO : 312-807-4364
70 W. MADISON ST SE DECISION MADE: 18-OCT-02
SUITE 3300 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60602
DEVICE: HCMI X-RAY
HEALTH CARE MFG., INC. 510(k) NO: K022667(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 22-OCT-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
HEALTH CARE MFG., INC. 510(k) NO: K022737(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 22-OCT-02
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIFE LD-12 KIT, MODEL 3338
HELENA LABORATORIES 510(k) NO: K022455(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 01-OCT-02
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: SPIFE CK KIT, MODEL 3332, 3333
HELENA LABORATORIES 510(k) NO: K022757(TRADITIONAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 11-OCT-02
PO BOX 752 510(k) STATEMENT
BEAUMONT, TX 77704
DEVICE: INRATIO SELF-TEST
HEMOSENSE, INC. 510(k) NO: K021923(TRADITIONAL)
ATTN: JUDITH BLUNT PHONE NO : 408-934-4126
600 VALLEY WAY SE DECISION MADE: 24-OCT-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBOND GLUMA INSIDE
HERAEUS KULZER, INC. 510(k) NO: K022612(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 219-299-6662
4315 S. LAFAYETTE BLVD. SE DECISION MADE: 28-OCT-02
SOUTH BEND, IN 46614 510(k) STATEMENT
DEVICE: HITACHI ALTAIRE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K022390(ABBREVIATED)
ATTN: DOUGLAS THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 11-OCT-02
TWINSBURG, OH 44087-2371 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZONS REUSABLE HOT BIOPSY FORCEPS
HORIZONS INTL. CORP. 510(k) NO: K022243(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
287 MONTERREY ST. SE DECISION MADE: 25-OCT-02
P.O.BOX 7273 510(k) STATEMENT
PONCE, PR 00717
DEVICE: HORIZONS REUSABLE POLYPECTOMY SNARES
HORIZONS INTL. CORP. 510(k) NO: K022268(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 787-842-4000
P.O. BOX 7273 SE DECISION MADE: 25-OCT-02
PONCE, PR 00732-7273 510(k) STATEMENT
DEVICE: DURACON CS TIBIAL INSERT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K021451(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-934-4359
59 ROUTE 17 SE DECISION MADE: 18-OCT-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMRS PRESS FIT STEMS WITH PUREFIX HA
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022403(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
59 ROUTE 17 SE DECISION MADE: 17-OCT-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K022651(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 17-OCT-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K023102(SPECIAL)
ATTN: DEBRA BING PHONE NO : 201-831-5413
59 ROUTE 17 SE DECISION MADE: 09-OCT-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSWORTH CORACO-CLAVICULAR SCREW
HOWMEDICA OSTEONICS CORP. 510(k) NO: K023294(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
59 ROUTE 17 SE DECISION MADE: 09-OCT-02
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
HYPOGUARD USA, INC. 510(k) NO: K022545(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 11-OCT-02
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-FLOW ELASTOMERIC PUMP WITH BOLUS
I-FLOW CORP. 510(k) NO: K023318(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 18-OCT-02
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITHWICK CAROTID SHUNT
IMPLANTABLE DEVICES 510(k) NO: K021608(TRADITIONAL)
ATTN: WILLIAM E MCPHERSON PHONE NO : 813-931-4201
P.O. BOX 270882 SE DECISION MADE: 22-OCT-02
TAMPA, FL 33688 510(k) STATEMENT
DEVICE: PROXILOCK HIP PROSTHESIS; SIZE 12/36
IMPLEX CORP. 510(k) NO: K022966(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 02-OCT-02
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUTEVENTILATOR
IMPOEX INTERNATIONAL, LTD. 510(k) NO: K012271(TRADITIONAL)
ATTN: SIVERT CLAESSON PHONE NO : 843-390-1610
500 EAGLE WAY #18 SE DECISION MADE: 04-OCT-02
LITTLE RIVER, SC 29566 510(k) STATEMENT
DEVICE: MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, PO
INDUSTRIAL CLOTHINGS, LTD. 510(k) NO: K022781(TRADITIONAL)
ATTN: S.N. HARI PHONE NO : 941 437 575
481A, PRINCE OF WALES AVE. SE DECISION MADE: 08-OCT-02
COLOMBO 14, SRI LANKA 510(k) STATEMENT
DEVICE: MODIFICATION TO FOCUS
INSTRUMENTARIUM CORP. 510(k) NO: K022630(TRADITIONAL)
ATTN: MARK MASON PHONE NO : 414-747-1030
300 WEST EDGERTON AVENUE SE DECISION MADE: 09-OCT-02
MILWAUKEE, WI 53207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
INTELLIGENT IMAGES SRL 510(k) NO: K022940(TRADITIONAL)
ATTN: MAURIZIO PIAGGIO PHONE NO : 390 105 299309
12/3 CORSO GALLIERA SE DECISION MADE: 11-OCT-02
GENOVA, GENOVA, ITALY I-16142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIOTRAVELLER, MODEL AA222
INTERACOUSTICS A/S, ASSENS 510(k) NO: K022728(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-941-4200
9675 WEST 76TH STREET SE DECISION MADE: 11-OCT-02
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: IQ 200 SYSTEM
INTL. REMOTE IMAGING SYSTEMS 510(k) NO: K022774(TRADITIONAL)
ATTN: HARVEY L KASDAN PHONE NO : 818-709-1244
9162 ETON AVE. SE DECISION MADE: 21-OCT-02
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
IRIDEX CORP. 510(k) NO: K022228(TRADITIONAL)
ATTN: JOHN D'ANGELO PHONE NO : 650-962-8100
1212 TERRA BELLA AVE. SE DECISION MADE: 08-OCT-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP
ISOLUX AMERICA 510(k) NO: K022384(TRADITIONAL)
ATTN: NIKOLAOS ANDREOULAKIS PHONE NO : 239-514-7475
1479 RAILHEAD BLVD. SE DECISION MADE: 18-OCT-02
NAPLES, FL 34110-8444 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: W-5
IVOCLAR VIVADENT, INC. 510(k) NO: K022811(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 09-OCT-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: UNIVERSAL CERAMIC SOLDER
IVOCLAR VIVADENT, INC. 510(k) NO: K022969(TRADITIONAL)
ATTN: ANDERJEET GULATI PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 18-OCT-02
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014
JAC-CELL MEDIC CORPORATION 510(k) NO: K020334(TRADITIONAL)
ATTN: JOHN GAGLIARDI PHONE NO : 513-573-0085
7736 WOODSIDE COURT SE DECISION MADE: 03-OCT-02
MAINEVILLE, OH 45039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEFORTE SYSTEM BONE PLATE
JEIL MEDICAL CORPORATION 510(k) NO: K023360(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 25-OCT-02
DEERFILED, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSCURE, MODEL 2910
KINETIC INSTRUMENTS, INC. 510(k) NO: K022862(TRADITIONAL)
ATTN: WILLIAM J BECKER PHONE NO : 203-743-0080
17 BERKSHIRE BLVD. SE DECISION MADE: 18-OCT-02
BETHEL, CT 06801 510(k) STATEMENT
DEVICE: KONICA DIRECT DIGITIZER REGIUS, MODEL 170
KONICA CORP. 510(k) NO: K023061(SPECIAL)
ATTN: SHINICHI YAMANAKA PHONE NO : 81 596 370190
319 AKENO, OBATA-CHO SE DECISION MADE: 11-OCT-02
WATARAI-GUN 510(k) STATEMENT
MIE-KEN, JAPAN 5190501
DEVICE: KOWA AUTOMATED TONOMETER KT-500
KOWA OPTIMED, INC. 510(k) NO: K013805(TRADITIONAL)
ATTN: FRANCES K WU PHONE NO : 202-737-4294
700 THIRTEENTH STREET, N.W. SE DECISION MADE: 11-OCT-02
SUITE 1200 510(k) STATEMENT
WASHINGTON, DC 20005
DEVICE: CLEARFIL AP-X PLT INTRO KIT
KURARAY MEDICAL INC. 510(k) NO: K022999(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 24-OCT-02
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL AP-X PLT
KURARAY MEDICAL INC. 510(k) NO: K023002(TRADITIONAL)
ATTN: MASAYA SASAKI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 25-OCT-02
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOL
LATEXX MANUFACTURING SDN.BHD. 510(k) NO: K022346(TRADITIONAL)
ATTN: TEOH CHOH SHEE PHONE NO : 605 891 1111
PT. 5054, P.O. BOX 9 SE DECISION MADE: 18-OCT-02
KAMUNTING INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
TAIPING, PERAK, MALAYSIA 34600
DEVICE: SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT
LIFESCAN, INC. 510(k) NO: K023194(SPECIAL)
ATTN: JOJN E HUGHES PHONE NO : 408-942-5903
1000 GIBRALTAR DR. SE DECISION MADE: 24-OCT-02
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CO
LUCID KOREA CO., LTD 510(k) NO: K021752(TRADITIONAL)
ATTN: DONG KUN LEE PHONE NO : 825 467 38326
748 KEOCHON-RI PONGHWA-EUP, SE DECISION MADE: 11-OCT-02
PONGHWA-KUN, 510(k) SUMMARY AVAILABLE FROM FDA
KYUNGSANGBUK-PROVINCE, REPUBLIC OF KOREA
DEVICE: MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER
LUMEND, INC. 510(k) NO: K023223(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
400 CHESAPEAKE DR. SE DECISION MADE: 24-OCT-02
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, D
LUMENIS, INC. 510(k) NO: K020839(TRADITIONAL)
ATTN: ALAN L VOSS PHONE NO : 209-736-9292
P.O. BOX 405 SE DECISION MADE: 11-OCT-02
ANGELS CAMP, CA 95221 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DEL
LUMENIS, INC. 510(k) NO: K022060(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 408-764-3604
2400 CONDENSA ST. SE DECISION MADE: 30-OCT-02
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORI
LUMENIS, INC. 510(k) NO: K022181(TRADITIONAL)
ATTN: KAREN L BAKER PHONE NO : 408-764-3603
2400 CONDENSA ST. SE DECISION MADE: 01-OCT-02
SANTA CLARA, CA 95051-0901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVUS SPECTRA
LUMENIS, INC. 510(k) NO: K022327(TRADITIONAL)
ATTN: KELLY MOHROR PHONE NO : 801-656-2612
3959 WEST 1820 SOUTH SE DECISION MADE: 16-OCT-02
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
MED-LOGICS, INC. 510(k) NO: K022716(TRADITIONAL)
ATTN: MARK MOYER PHONE NO : 949-582-3891
26061 MERIT CIRCLE, SUITE #102 SE DECISION MADE: 11-OCT-02
LAGUNA HILLS, CA 92653 510(k) STATEMENT
DEVICE: EXOMIO, MODEL 1.1
MEDCOM GMBH 510(k) NO: K022219(TRADITIONAL)
ATTN: IOANNIS NOMIKOS PHONE NO : 49 615 19514717
RUNDETURMSTR. 12 SE DECISION MADE: 07-OCT-02
DARMSTADT, HESSEN, GERMANY 64283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X
MEDCOMP 510(k) NO: K020936(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 11-OCT-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP VASCU-SHEATH INTRODUCER SET
MEDCOMP 510(k) NO: K022513(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 25-OCT-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDCOMP REPAIR KIT, MODEL ASPCRPK
MEDCOMP 510(k) NO: K022570(TRADITIONAL)
ATTN: FLORENCE A CAIKOSKI PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 31-OCT-02
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, M
MEDENNIUM, INC. 510(k) NO: K022043(TRADITIONAL)
ATTN: JULIAN ABADIA PHONE NO : 949-789-9000
15350 BARRANCA PKWY. SE DECISION MADE: 18-OCT-02
IRVINE, CA 92618 510(k) STATEMENT
DEVICE: MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K023307(TRADITIONAL)
ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891
5300 ADOLFO RD. SE DECISION MADE: 31-OCT-02
CAMARILLO, CA 93012 510(k) STATEMENT
DEVICE: PLASMALITE PULSED LIGHT SYSTEM
MEDICAL BIO CARE SWEDEN AB 510(k) NO: K022378(TRADITIONAL)
ATTN: CONNIE WHITE HOY PHONE NO : 530-666-7616
908 STETSON STREET SE DECISION MADE: 18-OCT-02
WOODLAND, CA 95776 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELCAM STOPCOCKS AND MANIFOLDS
MEDICAL DEVICE CONSULTANTS, INC. 510(k) NO: K022895(TRADITIONAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 18-OCT-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI-PLEX ADAPTER
MEDICAL DEVICE GROUP 510(k) NO: K010401(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 30-OCT-02
CROFTON, MD 21114 510(k) STATEMENT
DEVICE: REPROCESSED DISPOSABLE TROCARS
MEDICAL DEVICE SERVICES 510(k) NO: K022743(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY SE DECISION MADE: 09-OCT-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
MEDICAL DEVICE SERVICES 510(k) NO: K022748(TRADITIONAL)
ATTN: MARK ALDANA PHONE NO : 806-745-7718
1001 SLATON HWY SE DECISION MADE: 09-OCT-02
LUBBOCK, TX 79404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
MEDICAL ELECTRONIC DEVICES, INC. 510(k) NO: K023420(SPECIAL)
ATTN: THOMAS WENZEL PHONE NO : 310-618-0306
2807 OREGON CT. #D6 SE DECISION MADE: 25-OCT-02
TORRANCE, CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMAX QMA
MEDICAL METRICS, INC. 510(k) NO: K022585(TRADITIONAL)
ATTN: MARK LAMP PHONE NO : 832-328-0660
10540 ROCKELY ROAD SE DECISION MADE: 11-OCT-02
SUITE 200 510(k) STATEMENT
HOUSTON, TX 77099
DEVICE: TIMEX DIGITAL ORAL THERMOMETERS; TIMEX ACCUCURVE ORAL THERMOMETE
MEDPORT, INC. 510(k) NO: K023069(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 18-OCT-02
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAMELOCK; FRAMELOCK ACCESSORIES
MEDTRONIC XOMED, INC. 510(k) NO: K022370(TRADITIONAL)
ATTN: B.L. MCDERMOTT PHONE NO : 904-332-8562
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 18-OCT-02
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
MEDTRONIC, INC. 510(k) NO: K022238(TRADITIONAL)
ATTN: MARY ELLEN BEST PHONE NO : 763-514-4846
7000 CENTRAL AVENUE NE SE DECISION MADE: 09-OCT-02
MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPORT ASPIRATION CATHETER
MEDTRONIC, INC. 510(k) NO: K023303(SPECIAL)
ATTN: FRED L BOUCHER PHONE NO : 978-777-0042
37A CHERRY HILL DR. SE DECISION MADE: 29-OCT-02
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WOR
MENTOR CORP. 510(k) NO: K011493(TRADITIONAL)
ATTN: GEORGE HOEDEMAN PHONE NO :
9727 VALLEY VIEW ROAD SE DECISION MADE: 01-OCT-02
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25,
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K022117(TRADITIONAL)
ATTN: STEPHANIE A ERSKINE PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 11-OCT-02
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOXELPLUS PACS
MEVISYS CO. LTD 510(k) NO: K022692(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD SE DECISION MADE: 11-OCT-02
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA CYCLOSPORINE PLUS ASSAY
MICROGENICS CORP. 510(k) NO: K023208(TRADITIONAL)
ATTN: MARK HAMILTON SMITH PHONE NO : 510-979-5169
46360 FREMONT BLVD. SE DECISION MADE: 24-OCT-02
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
MICROTECH 510(k) NO: K022535(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 22-OCT-02
IRVINE, CA 92606 510(k) STATEMENT
DEVICE: SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
MIDI, INC. 510(k) NO: K020689(TRADITIONAL)
ATTN: WILLIAMS STIMSON PHONE NO : 302-737-4297
125 SANDY DR. SE DECISION MADE: 31-OCT-02
NEWARK, DE 19713-1148 510(k) STATEMENT
DEVICE: MOIST PUNCTAL PLUG SYSTEM
MOIST MEDICAL INC. 510(k) NO: K021936(TRADITIONAL)
ATTN: GEORGE W MURRAY PHONE NO : 901-756-9722
2180 WICKERSHAM LANE SE DECISION MADE: 16-OCT-02
GERMANTOWN, TN 38139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPAS
MORGAN SCIENTIFIC, INC. 510(k) NO: K021200(TRADITIONAL)
ATTN: PATRICK F MORGAN PHONE NO : 978-521-4440
151 ESSEX ST. SE DECISION MADE: 18-OCT-02
HAVERHILL, MA 01832 510(k) STATEMENT
DEVICE: KONRAD, MODEL V.2.0
MRC SYSTEMS GMBH 510(k) NO: K022307(TRADITIONAL)
ATTN: MARK-ALEKSI KELLER-REICHENBPHONE NO : 496 221 1380300
HANS-BUNTE-STR. 10 SE DECISION MADE: 08-OCT-02
HEIDELBERG, GERMANY 69123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QSC-63-INT SHOULDER ARRAY COIL SET
MRI DEVICES CORP. 510(k) NO: K022910(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 03-OCT-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
MRI DEVICES CORP. 510(k) NO: K023130(SPECIAL)
ATTN: WILLIAM J DINEHART PHONE NO : 352-336-0010
1515 PARAMOUNT DR. SE DECISION MADE: 11-OCT-02
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BBC-63-GE BREAST ARRAY COIL
MRI DEVICES CORP. 510(k) NO: K023164(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 11-OCT-02
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: DR. JAPAN FACIL POINT SPINAL NEEDLE
MYCO MEDICAL, INC. 510(k) NO: K020934(TRADITIONAL)
ATTN: SAM KUMAR PHONE NO : 800-454-6926
113 CENTRE WEST COURT SE DECISION MADE: 25-OCT-02
CARY, NC 27513 510(k) STATEMENT
DEVICE: NEICH NM ADVANCE CATHETER SHEATH INTRODUCER
NEICH MEDICAL(SHENZHEN)COMPANY, LT510(k) NO: K020964(TRADITIONAL)
ATTN: HUANG JIN PHONE NO : 867 552 3580181
1 JINKUI ROAD, FUTIAN FREE SE DECISION MADE: 11-OCT-02
TRADE ZONE 510(k) STATEMENT
SHENZHEN, GUANGDONG, CHINA 518038
DEVICE: NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
NEURORECOVERY, INC. 510(k) NO: K022638(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 31-OCT-02
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NBD CEMENT RESTRICTOR DEVICE
NEW BUSINESS DEVELOPMENT, LLC 510(k) NO: K021788(TRADITIONAL)
ATTN: TIM B LUSBY PHONE NO : 678-852-5504
605 INDUSTRIAL COURT SE DECISION MADE: 04-OCT-02
WOODSTOCK, GA 30189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWDEAL K WIRE
NEWDEAL S.A. 510(k) NO: K022599(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 30-OCT-02
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTI
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K022356(TRADITIONAL)
ATTN: JAMES A RYBSKI PHONE NO : 949-940-7358
1311 CALLE BATIDO SE DECISION MADE: 25-OCT-02
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPE
NICHOLS INSTITUTE DIAGNOSTICS 510(k) NO: K022472(TRADITIONAL)
ATTN: JIMMY WONG PHONE NO : 949-940-7260
1311 CALLE BATIDO SE DECISION MADE: 09-OCT-02
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K023475(SPECIAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON STREET SE DECISION MADE: 24-OCT-02
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO BIO-FLEX CATHETER
NIPRO MEDICAL CORP. 510(k) NO: K022756(TRADITIONAL)
ATTN: KAELYN B HADLEY PHONE NO : 859-224-8256
1384 COPPERFIELD COURT SE DECISION MADE: 18-OCT-02
LEXINGTON, KY 40514-1268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
NOBEL BIOCARE AB 510(k) NO: K022562(TRADITIONAL)
ATTN: KATHLEEN DRAGOVICH PHONE NO : 714-282-5073
22725 SAVI RANCH PARKWAY SE DECISION MADE: 11-OCT-02
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL
NUCLETRON CORPORATION 510(k) NO: K022739(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 25-OCT-02
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOT PRO (220V), MODEL 131.099
NUCLETRON CORPORATION 510(k) NO: K022741(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 410-312-4100
7080 COLUMBIA GATEWAY DR. SE DECISION MADE: 24-OCT-02
COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE PREMIXED DIALYSATE
NXSTAGE MEDICAL, INC. 510(k) NO: K022913(TRADITIONAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION STREET SE DECISION MADE: 21-OCT-02
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843 THIRD PARTY REVIEW
DEVICE: NICALERT
NYMOX PHARMACEUTICAL CORPORATION 510(k) NO: K021688(TRADITIONAL)
ATTN: MICHAEL MUNZAR PHONE NO : 514-332-3222
230 WEST PASSAIC ST. SE DECISION MADE: 18-OCT-02
MAYWOOD, NJ 07607 510(k) STATEMENT
DEVICE: DISPOSABLE N-PE MICROKERATOME BLADES
OASIS MEDICAL, INC. 510(k) NO: K022205(TRADITIONAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 626-914-2891
514 SOUTH VERMONT AVENUE SE DECISION MADE: 03-OCT-02
GLENDORA, CA 91741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT
OEMEDIC INTERNATIONAL, INC. 510(k) NO: K021446(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 11-OCT-02
LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-13
OLYMPUS WINTER & IBE GMBH 510(k) NO: K020507(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 08-OCT-02
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAL INTEGRITY GENERAL SHAPED FIBER
OPTICAL INTEGRITY, INC. 510(k) NO: K022338(TRADITIONAL)
ATTN: JOE D BROWN PHONE NO : 850-233-5512
8317 FRONT BEACH ROAD SE DECISION MADE: 16-OCT-02
SUITE 21 510(k) SUMMARY AVAILABLE FROM FDA
PANAMA CITY BEACH, FL 32407-4893
DEVICE: MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
ORGAN RECOVERY SYSTEMS, INC. 510(k) NO: K022391(SPECIAL)
ATTN: STANLEY HARRIS PHONE NO : 843-722-6756
701 EAST BAY STREET SE DECISION MADE: 21-OCT-02
SUITE 433 510(k) SUMMARY AVAILABLE FROM FDA
CHARLESTON, SC 29466
DEVICE: 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
OSTEOMED CORP. 510(k) NO: K023260(TRADITIONAL)
ATTN: DAWN T HOLDEMAN PHONE NO : 972-241-3401
3750 REALTY RD. SE DECISION MADE: 18-OCT-02
ADDISON, TX 75001-4311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077
OSYPKA MEDICAL, INC. 510(k) NO: K022939(SPECIAL)
ATTN: MARKUS J OSYPKA PHONE NO : 858-459-2312
7463 DRAPER AVENUE SE DECISION MADE: 03-OCT-02
LA JOLLA, CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
OTTO BOCK HEALTHCARE 510(k) NO: K022924(TRADITIONAL)
ATTN: E.P. (BERT) HARMAN PHONE NO : 763-553-9464
2 CARLSON PARKWAY N. SE DECISION MADE: 17-OCT-02
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447-4467
DEVICE: PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M1
PAN-AMERICA HYPERBARICS, INC. 510(k) NO: K021689(ABBREVIATED)
ATTN: W. T WORKMAN PHONE NO : 210-490-6999
18111 COPPER RIDGE DRIVE SE DECISION MADE: 24-OCT-02
SAN ANTONIO, TX 78259-3612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+
PAN-AMERICA HYPERBARICS, INC. 510(k) NO: K021690(ABBREVIATED)
ATTN: W.T. WORKMAN PHONE NO : 210-490-6999
18111 COPPER RIDGE DRIVE SE DECISION MADE: 24-OCT-02
SAN ANTONIO, TX 78259-3612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
PAN-AMERICA HYPERBARICS, INC. 510(k) NO: K021693(ABBREVIATED)
ATTN: W.T. WORKMAN PHONE NO : 210-490-6999
18111 COPPER RIDGE DRIVE SE DECISION MADE: 24-OCT-02
SAN ANTONIO, TX 78259-3612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
PARADIGM MEDICAL INDUSTRIES, INC. 510(k) NO: K023245(TRADITIONAL)
ATTN: DAVID M SILVER PHONE NO : 801-977-8970
2355 SOUTH 1070 WEST SE DECISION MADE: 21-OCT-02
SALT LAKE CITY, UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EB-1830T3, VIDEO BRONCHOSCOPE
PENTAX PRECISION INSTRUMENT CORP. 510(k) NO: K023376(SPECIAL)
ATTN: PAUL SILVA PHONE NO : 845-365-0700
30 RAMLAND RD. SE DECISION MADE: 16-OCT-02
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
PERKINELMER LIFE SCIENCES 510(k) NO: K021541(TRADITIONAL)
ATTN: HANK JUSKE PHONE NO : 330-825-4525
3985 EASTERN RD. SE DECISION MADE: 28-OCT-02
NORTON, OH 44203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K023262(TRADITIONAL)
ATTN: TAN KONG CHANG PHONE NO : 033 291 2657
41720 KLANG, SE DECISION MADE: 28-OCT-02
P.O. BOX 188, 41720 KLANG 510(k) STATEMENT
SELANGOR, DARUL EHSAN, MALAYSIA 42100
DEVICE: PHILIPS DIGITAL IMAGING OPTION RELEASE 1
PHILIPS MEDICAL SYSTEMS 510(k) NO: K023440(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 30-OCT-02
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-8431 THIRD PARTY REVIEW
DEVICE: PHILIPS MULTIDIAGNOST ELEVA
PHILIPS MEDICAL SYSTEMS 510(k) NO: K023441(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY SE DECISION MADE: 30-OCT-02
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-8431 THIRD PARTY REVIEW
DEVICE: PHILIPS HARMONY RELEASE 1
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K022788(TRADITIONAL)
ATTN: LYNN T HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 25-OCT-02
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041-3003
DEVICE: MODEL 4310 PSARRAY2 EEG ELECTRODE
PHYSIOMETRIX, INC. 510(k) NO: K020670(SPECIAL)
ATTN: DAWN E FRAZER PHONE NO : 978-670-2422
FIVE BILLERICA PARK, SE DECISION MADE: 08-OCT-02
101 BILLERICA AVE. 510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862
DEVICE: PSA4000 EEG MONITOR WITH FRONTAL PSI
PHYSIOMETRIX, INC. 510(k) NO: K020671(SPECIAL)
ATTN: DAWN E FRAZER PHONE NO : 978-670-2422
FIVE BILLERICA PARK, SE DECISION MADE: 04-OCT-02
101 BILLERICA AVE. 510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862
DEVICE: QIVA
PIE MEDICAL IMAGING B.V. 510(k) NO: K021495(TRADITIONAL)
ATTN: COLLEEN DENSMORE PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 01-OCT-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VKS KNEE SYSTEM
PLUS ORTHOPEDICS 510(k) NO: K022204(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-550-3800
6055 LUSK BLVD. SE DECISION MADE: 18-OCT-02
SAN DIEGO, CA 92121-2700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLIFY COMPACT RESUSCITATOR
POLYMED (XIAMEN) PLASTIC INDUSTRIA510(k) NO: K021716(TRADITIONAL)
ATTN: SHAN HUA YING PHONE NO : 865 925 624688
UNIT B,1-5 F,WAREHOUSE & PROC. SE DECISION MADE: 08-OCT-02
COMPLEX BLDG. XIANGYU F.T.Z. 510(k) STATEMENT
XIAMEN, CHINA
DEVICE: PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X
PORGES S.A. 510(k) NO: K013921(TRADITIONAL)
ATTN: BERNARD ISMAEL PHONE NO : 331 460 13232
CENTRE D'AFFAIRES SE DECISION MADE: 17-OCT-02
LA BOURSIDIERE 510(k) SUMMARY AVAILABLE FROM FDA
LE PLESSIS ROBINSON CEDEX, FRANCE
DEVICE: PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07,
PORGES S.A. 510(k) NO: K021856(TRADITIONAL)
ATTN: BERNARD ISMAEL PHONE NO : 33 1 46013232
CENTRE D'AFFAIRES SE DECISION MADE: 17-OCT-02
LA BOURSIDIERE 510(k) SUMMARY AVAILABLE FROM FDA
LE PLESSIS ROBINSON CEDEX, FRANCE 92357
DEVICE: CLEAR-IT ANTI-FOG, MODEL PS003
PRESERVATION SOLUTIONS, INC. 510(k) NO: K022826(TRADITIONAL)
ATTN: JOHN R DALPEE PHONE NO : 952-944-8420
8300 W. 110TH STREET SE DECISION MADE: 09-OCT-02
BLOOMINGTON, MN 55438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
PRINCETON BIOMEDITECH CORP. 510(k) NO: K022946(TRADITIONAL)
ATTN: JEMO KANG PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 08-OCT-02
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ESOP CO-CR FEMORAL HEADS
PRO-ACTIVE HEALTHCARE 510(k) NO: K023375(SPECIAL)
ATTN: ANDRE WEITH PHONE NO : 202-835-1346
815 CONNECTICUT AVE. NW SE DECISION MADE: 25-OCT-02
SUITE 800 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: 56 SERIES JET NEBULIZER
PROJECT MARKETING 510(k) NO: K021443(ABBREVIATED)
ATTN: TERRY O'BRIEN PHONE NO : 919-468-9552
112 CAVISTON WAY SE DECISION MADE: 21-OCT-02
CARY, NC 27560 510(k) STATEMENT
DEVICE: KOKOMATE
PULMONARY DATA SERVICES, INC. 510(k) NO: K022276(ABBREVIATED)
ATTN: JIM LEWIS PHONE NO : 303-666-5555
908 MAIN ST. SE DECISION MADE: 04-OCT-02
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT SEMI-GEL ETCH
PULPDENT CORPORATION 510(k) NO: K022492(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 11-OCT-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULPDENT CALCIUM HYDROXIDE PREPARATION
PULPDENT CORPORATION 510(k) NO: K022734(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND STREET SE DECISION MADE: 07-OCT-02
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER S
QINGDAO BESTEX RUBBER & PLASTIC PR510(k) NO: K022566(TRADITIONAL)
ATTN: ZECHUAN SHAO PHONE NO : 408-980-1348
2576 LAFAYETTE STREET SE DECISION MADE: 15-OCT-02
SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIANALYZER, MODEL 12710
RADI MEDICAL SYSTEMS AB 510(k) NO: K022188(TRADITIONAL)
ATTN: MATS GRANLUND PHONE NO : 461 816 1000
PALMBLADSGATAN 10 SE DECISION MADE: 03-OCT-02
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBRASCAN CR-1 FILMLESS
RADIOGRAPHIC DIGITAL IMAGING, INC.510(k) NO: K022810(TRADITIONAL)
ATTN: ANALEI SAMASEIA PHONE NO : 310-921-9559
20406 EARL STREET SE DECISION MADE: 11-OCT-02
TORRANCE, CA 90503 510(k) STATEMENT
DEVICE: RANDOX APOLIPOPROTEIN CALIBRATOR
RANDOX LABORATORIES, LTD. 510(k) NO: K023158(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 442 894 422413
55 DIAMOND RD. SE DECISION MADE: 24-OCT-02
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: MOISTURESTAY (REVLON)
RAYMOND INDUSTRIAL, LTD. 510(k) NO: K022626(TRADITIONAL)
ATTN: ROBERT T WAGNER PHONE NO : 727-578-4060
972 WEEDON DR. NE SE DECISION MADE: 29-OCT-02
SAINT PETERSBURG, FL 33702 510(k) STATEMENT
DEVICE: RHINOSTREAM RHINOMANOMETER MODULE
RHINOMETRICS A/S 510(k) NO: K022311(TRADITIONAL)
ATTN: DAN EGGAN PHONE NO : 952-278-5547
9675 WEST 95TH STREET SE DECISION MADE: 04-OCT-02
MINNEAPOLIS, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RITA SYSTEM
RITA MEDICAL SYSTEMS 510(k) NO: K021329(TRADITIONAL)
ATTN: ERIN MAZZONE PHONE NO : 650-314-3439
967 NORTH SHORELINE BLVD. SE DECISION MADE: 09-OCT-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K020831(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
9115 HAGUE RD. SE DECISION MADE: 24-OCT-02
P.O. BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
ROCHE DIAGNOSTICS CORP. 510(k) NO: K021190(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
9115 HAGUE RD. SE DECISION MADE: 25-OCT-02
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIO ID+(RZ153+)
ROZINN ELECTRONICS, INC. 510(k) NO: K022540(TRADITIONAL)
ATTN: MARK ROSOFF PHONE NO : 718-386-5526
71-22 MYRTLE AVE. SE DECISION MADE: 24-OCT-02
GLENDALE, NY 11385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILUX, Z-TONE, ACRY ROCK
RUTHIBRAS IMP.EXP.COM.DE MATERIAIA510(k) NO: K022299(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 07-OCT-02
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: S&T; SINGLE USE MICRO ANASTOMOSIS CLAMP
S & T AG 510(k) NO: K022754(TRADITIONAL)
ATTN: BERNHARD TEITZ PHONE NO : 847-549-1410
28438 BALLARD DR SE DECISION MADE: 16-OCT-02
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: SAS STREPALERT
SA SCIENTIFIC, INC. 510(k) NO: K023270(TRADITIONAL)
ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 17-OCT-02
SAN ANTONIO, TX 78240 510(k) STATEMENT
DEVICE: SANARUS INDICA MARKER SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K020054(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-768-1184
5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 16-OCT-02
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANARUS VISICA TREATMENT SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K022314(TRADITIONAL)
ATTN: SETH STABINSKY PHONE NO : 925-460-6080
5880 WEST LAS POSITAS,SUITE 52 SE DECISION MADE: 15-OCT-02
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
SCHICK TECHNOLOGIES, INC. 510(k) NO: K022953(SPECIAL)
ATTN: DANIEL MICHAELI PHONE NO : 718-937-5765
30-00 47TH AVE. SE DECISION MADE: 02-OCT-02
LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE 1320 LASER SYSTEM
SCITON, INC. 510(k) NO: K022381(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
845 COMMERCIAL STREET SE DECISION MADE: 18-OCT-02
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
SERADYN 510(k) NO: K023058(TRADITIONAL)
ATTN: LISA BROWN PHONE NO : 317-610-3800
7998 GEORGETOWN RD. SE DECISION MADE: 24-OCT-02
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46268
DEVICE: VINYL EXAMINATION GLOVES, PRE-POWDERED
SHANDONG JIAZHAN PLASTIC PRODUCTS 510(k) NO: K023145(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 11-OCT-02
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE
SHANDONG JIAZHAN PLASTIC PRODUCTS 510(k) NO: K023235(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 18-OCT-02
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
SHANGHAI JIAWANG INDUSTRIAL CO. LT510(k) NO: K023428(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 25-OCT-02
SPARKS, NV 89434-9550 510(k) STATEMENT
DEVICE: ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K023343(TRADITIONAL)
ATTN: DANNY WANG PHONE NO : 862 157 727722
#1 BIYU RD., CANGQIAO TOWNSHIP SE DECISION MADE: 28-OCT-02
SONGJIANG SHANGHAI, CHINA 201600 510(k) STATEMENT
DEVICE: E.CAM COMPUTER / E.SOFT WORKSTATION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K023190(SPECIAL)
ATTN: RICHARD S DEMKE PHONE NO : 847-304-7516
2501 NORTH BARRINGTON RD. SE DECISION MADE: 24-OCT-02
HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHS ACETABULAR COMPONENT
SIGNAL MEDICAL CORP. 510(k) NO: K022382(TRADITIONAL)
ATTN: LOUIS SERAFIN PHONE NO : 810-966-3917
3777 LAPEER RD. 3-C SE DECISION MADE: 04-OCT-02
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
SMITH & NEPHEW, INC. 510(k) NO: K020948(TRADITIONAL)
ATTN: JASON BILOBRAM PHONE NO : 508-261-3658
160 DASCOMB RD. SE DECISION MADE: 09-OCT-02
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATION
SMITH & NEPHEW, INC. 510(k) NO: K021815(ABBREVIATED)
ATTN: GINO J ROUSS PHONE NO : 901-399-6707
1450 BROOKS ROAD SE DECISION MADE: 17-OCT-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW HIP SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K022902(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS ROAD SE DECISION MADE: 02-OCT-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL HIP FEMORAL HEADS AND LINERS
SMITH & NEPHEW, INC. 510(k) NO: K022958(SPECIAL)
ATTN: KIM KELLY PHONE NO : 901-399-6566
1450 E. BROOKS ROAD SE DECISION MADE: 02-OCT-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
SMITH & NEPHEW, INC. 510(k) NO: K023021(SPECIAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-261-3770
130 FORBES BLVD. SE DECISION MADE: 04-OCT-02
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K023053(SPECIAL)
ATTN: STEVEN JACKSON PHONE NO : 405-936-3085
3600 NW 138TH STREET SE DECISION MADE: 03-OCT-02
OKLAHOMA CITY, OK 73134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET-X TIN COATED HALF PINS
SMITH & NEPHEW, INC. 510(k) NO: K023134(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 09-OCT-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON POROUS PLUS HA HIP STEMS
SMITH & NEPHEW, INC. 510(k) NO: K023302(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 E. BROOKS ROAD SE DECISION MADE: 25-OCT-02
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCOMPASS SPINAL FIXATION SYSTEM
SPINAL CONCEPTS, INC. 510(k) NO: K021564(TRADITIONAL)
ATTN: DAVID M HOOPER PHONE NO : 512-918-2700
12012 TECHNOLOGY BLVD., #100 SE DECISION MADE: 25-OCT-02
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36,
SPIRE BIOMEDICAL, INC. 510(k) NO: K022620(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 11-OCT-02
BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL SPORVIEW STEAM BI TEST PACK
SPS MEDICAL SUPPLY CORP. 510(k) NO: K022706(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 25-OCT-02
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIVESIRE ELECTROPHYSIOLOGY CATHETER
ST. JUDE MEDICAL 510(k) NO: K022380(TRADITIONAL)
ATTN: JIM M TAUFEN PHONE NO : 952-933-4700
14900 MINNETONKA INDUSTRIAL BL SE DECISION MADE: 01-OCT-02
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
ST. JUDE MEDICAL 510(k) NO: K023447(SPECIAL)
ATTN: GLENN JACQUES PHONE NO : 952-238-9356
14901 DEVEAU PL. SE DECISION MADE: 31-OCT-02
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
STEREOTAXIS, INC. 510(k) NO: K022565(SPECIAL)
ATTN: PETER A TAKES PHONE NO : 314-615-6964
4041 FOREST PARK AVENUE SE DECISION MADE: 08-OCT-02
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED IMAGING CATHETERS
STERILMED, INC. 510(k) NO: K012537(TRADITIONAL)
ATTN: PATRICK FLEISCHHACKER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH SE DECISION MADE: 11-OCT-02
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT CORONARY PERFUSION CANNULAE
STOCKERT INSTRUMENTE GMBH 510(k) NO: K022280(ABBREVIATED)
ATTN: LYNNE LEONARD PHONE NO : 303-697-4615
20193 GOINS DRIVE SE DECISION MADE: 11-OCT-02
MORRISON, CO 80465 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT V172-28 VENOUS FEMORAL CANNULA
STOCKERT INSTRUMENTE GMBH 510(k) NO: K022321(TRADITIONAL)
ATTN: SHAWN RIEDEL PHONE NO : 303-467-6521
14401 W. 65TH WAY SE DECISION MADE: 09-OCT-02
ARVADA, CO 80004-3599 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDI
SUMMIT MEDICAL LTD. 510(k) NO: K022477(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 44 1763222505
BUSINESS & TECHNOLOGY CENTRE SE DECISION MADE: 25-OCT-02
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE HERTFORDSHIRE, UNITED KINGDOM SGI 2DX
DEVICE: SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTE
SUMMIT MEDICAL LTD. 510(k) NO: K022489(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 44 1763222505
BUSINESS & TECHNOLOGY CENTRE SE DECISION MADE: 09-OCT-02
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE HERTFORDSHIRE, UNITED KINGDOM SGI 2DX
DEVICE: "POWDER FREE ELASTIC VINYL EXAMINATION GLOVES"
SUN FLOWER GLOVES CO., LTD. 510(k) NO: K022604(TRADITIONAL)
ATTN: W. J. HU PHONE NO : 886 658 30767
187 CHIEN-YEH RD., SHANHUA SE DECISION MADE: 25-OCT-02
TAINAN HSIEN, CHINA (TAIWAN) 74103510(k) STATEMENT
DEVICE: SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
SURGICAL TECHNOLOGY LABORATORIES, 510(k) NO: K021889(TRADITIONAL)
ATTN: CAMERON J FORDYCE PHONE NO : 216-431-5055
1588 EAST 40TH ST. SE DECISION MADE: 16-OCT-02
CLEVELAND, OH 44103 510(k) STATEMENT
DEVICE: CLEAN 'N' OIL
SVENSKA DENTAL INSTRUMENTS AB 510(k) NO: K022264(TRADITIONAL)
ATTN: EMMA BERGQUIST PHONE NO : 46 8 50650575
PO BOX 723 SE DECISION MADE: 02-OCT-02
FINVIDS VAG 8 510(k) STATEMENT
UPPLANDS VAESBY, SWEDEN 194 27
DEVICE: LIGHT TIP
SVENSKA DENTAL INSTRUMENTS AB 510(k) NO: K022265(TRADITIONAL)
ATTN: EMMA BERGQUIST PHONE NO : 46 8 50650575
PO BOX 723 SE DECISION MADE: 02-OCT-02
FINVIDS VAG 8 510(k) STATEMENT
UPPLANDS VAESBY, SWEDEN 194 27
DEVICE: AURORA SR
SYNERON MEDICAL LTD. 510(k) NO: K022266(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 67 404616
POB 550 SE DECISION MADE: 03-OCT-02
YOKNEAM ELITE, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTPACS
TAIWAN ELECTRONIC DATA PROCESSING 510(k) NO: K022710(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1100 LAKEVIEW BLVD. SE DECISION MADE: 11-OCT-02
DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "BALDUR" BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLO
TANGSHAN ZHONGHONG PULIN FOOD PROD510(k) NO: K022336(TRADITIONAL)
ATTN: DAVID HU PHONE NO : 510-477-9631
33235 TRANSIT AVENUE SE DECISION MADE: 11-OCT-02
UNION CITY, CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANSPACH POWERED KERRISON SYSTEM (PKS)
THE ANSPACH EFFORT, INC. 510(k) NO: K022907(TRADITIONAL)
ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 21-OCT-02
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UTERINE INJECTOR
THOMAS MEDICAL, INC. 510(k) NO: K022503(TRADITIONAL)
ATTN: THOMAS J ZINNANTI PHONE NO : 770-360-7778
4100-C NINE MCFARLAND DRIVE SE DECISION MADE: 25-OCT-02
ALPHARETTA, GA 30004 510(k) STATEMENT
DEVICE: PERMACOL
TISSUE SCIENCE LABORATORIES, PLC 510(k) NO: K021056(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST. N.W. SE DECISION MADE: 31-OCT-02
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOKUYAMA REBASE II
TOKUYAMA AMERICA, INC. 510(k) NO: K022641(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000
2000 M STREET (SUITE 700) SE DECISION MADE: 02-OCT-02
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K022824(SPECIAL)
ATTN: FLORIAN EISENBERGER PHONE NO : 49 893 2175830
EDISONSTRASSE 6 SE DECISION MADE: 17-OCT-02
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE
TOP GLOVE MEDICAL (THAILAND) CO., 510(k) NO: K022016(TRADITIONAL)
ATTN: AUDIE SEOW PHONE NO : 006 674 412913
NO 58 MOO 7 KARNCHANAWANICH RD SE DECISION MADE: 15-OCT-02
PRIK, SADAO 510(k) STATEMENT
SONGKHLA, THAILAND 90120
DEVICE: OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K023207(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 09-OCT-02
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K022656(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-216-9036
29299 CLEMENS RD., SUITE 1-K SE DECISION MADE: 08-OCT-02
WESTLAKE, OH 44145 510(k) STATEMENT
DEVICE: TGDC-01 "PRA"
TRUEVISION INSTRUMENTS 510(k) NO: K021937(TRADITIONAL)
ATTN: RALF THOMAIER PHONE NO : 415-643-9838
4220 CESAR CHAVEZ #536 SE DECISION MADE: 11-OCT-02
SAN FRANCISCO, CA 94131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TQ1
ULTRADENT PRODUCTS, INC. 510(k) NO: K023042(TRADITIONAL)
ATTN: MARKUS GEE PHONE NO : 800-552-5512
505 WEST 10200 SOUTH SE DECISION MADE: 28-OCT-02
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: USG 2000SA
ULTRAGUIDE LTD. 510(k) NO: K023227(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 22-OCT-02
HASBROUCK HEIGHTS, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTEMIS
ULTRALINK, LLC. 510(k) NO: K021333(TRADITIONAL)
ATTN: GEORGE D WISEMAN PHONE NO : 727-527-1277
2083 HAWAII AVE N.E. SE DECISION MADE: 08-OCT-02
ST PETERSBURG, FL 33707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
USA INSTRUMENTS, INC. 510(k) NO: K022582(TRADITIONAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000
1515 DANNER DRIVE SE DECISION MADE: 22-OCT-02
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED TROCAR
VANGUARD MEDICAL CONCEPTS 510(k) NO: K022763(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-904-1628
5307 GREAT OAK DRIVE SE DECISION MADE: 09-OCT-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED PULSE OXIMETER SENSORS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K012344(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 04-OCT-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K022316(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 863-904-1628
5307 GREAT OAK DR. SE DECISION MADE: 10-OCT-02
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARISOURCE BREAST TEMPLATE SYSTEM
VARIAN MEDICAL SYSTEMS 510(k) NO: K023220(SPECIAL)
ATTN: LINDA S NASH PHONE NO : 650-424-6990
3100 HANSEN WAY M/S F055 SE DECISION MADE: 25-OCT-02
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUITY RADIATION THERAPY SIMULATOR
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K023052(SPECIAL)
ATTN: LINDA S NASH PHONE NO : 450-424-6990
3100 HANSEN WAY SE DECISION MADE: 11-OCT-02
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITA IN-CERAM YZ CUBES FOR CEREC
VIDENT 510(k) NO: K022996(SPECIAL)
ATTN: BARBARA LEWANDOWSKI PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 09-OCT-02
BREA, CA 92821 510(k) STATEMENT
DEVICE: FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
VITAL SCIENTIFIC N.V. 510(k) NO: K021976(TRADITIONAL)
ATTN: ISRAEL M STEIN PHONE NO : 617-527-9933
ONE GATEWAY CENTER SUITE 411 SE DECISION MADE: 25-OCT-02
NEWTON, MA 02458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCIRCLE LOCALIZATION DEVICE
VIVANT MEDICAL, INC. 510(k) NO: K022286(TRADITIONAL)
ATTN: STEVEN KIM PHONE NO : 650-694-2000
1916-A OLD MIDDLEFIELD WAY SE DECISION MADE: 11-OCT-02
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWINKY STAR
VOCO GMBH 510(k) NO: K022797(ABBREVIATED)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 10-OCT-02
BEND, OR 97702 510(k) STATEMENT
DEVICE: CONTACT LASER & DIAGNOSTIC LENSES
VOLK OPTICAL, INC. 510(k) NO: K023221(SPECIAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE ROAD SE DECISION MADE: 11-OCT-02
SUITE 30 510(k) STATEMENT
ROCKVILLE, MD 20850
DEVICE: VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3
VOLUME INTERACTIONS PTE LTD 510(k) NO: K022938(TRADITIONAL)
ATTN: JOHN BABY PHONE NO : 65 622 26962
5 SHENTON WAY SE DECISION MADE: 25-OCT-02
#37-04 UIC BUILDING 510(k) SUMMARY AVAILABLE FROM FDA
SINGAPORE, SINGAPORE
DEVICE: VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX
VOMED VOLZER MEDIZINTECHNIK GMBH &510(k) NO: K022257(TRADITIONAL)
ATTN: DAGMAR MASER PHONE NO : 31 20 4289591
AMSTEL 320-I SE DECISION MADE: 04-OCT-02
AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT
DEVICE: BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MO
VSM MEDTECH LTD. 510(k) NO: K023055(SPECIAL)
ATTN: DARYL WISDAHL PHONE NO : 604 738 8763
675 WEST HASTINGS ST., 15TH FL SE DECISION MADE: 22-OCT-02
VANCOUVER, B.C., CANADA V6B 1N2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST
WAISMED LTD. 510(k) NO: K022415(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 977 18130
117 AHUZAH ST SE DECISION MADE: 11-OCT-02
RA'ANANNA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
WELCH ALLYN, INC. 510(k) NO: K023495(SPECIAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4100
4341 STATE STREET RD. SE DECISION MADE: 31-OCT-02
SKANEATELES FALLS, NY 13153-0220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KERADEC
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K022663(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 13705219
SCHWENNINGER STRABE 13 SE DECISION MADE: 31-OCT-02
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK CYSTOTOME
WILSON-COOK MEDICAL, INC. 510(k) NO: K022595(TRADITIONAL)
ATTN: MARGARET J POSNER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 17-OCT-02
WINSTON-SALEM, NC 27105-4191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRTUS (TM) RESPIRATORY SYSTEM #SRS 001
WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K020641(TRADITIONAL)
ATTN: JONATHAN LEE PHONE NO : 904-716-7534
138 SPARTINA AVE. SE DECISION MADE: 29-OCT-02
ST. AUGUSTINE, FL 32080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE GRAFT SYRINGE, MODEL 8600-00X0
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K023088(TRADITIONAL)
ATTN: ROGER D BROWN PHONE NO : 901-867-4457
5677 AIRLINE RD. SE DECISION MADE: 02-OCT-02
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRIL
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K022904(TRADITIONAL)
ATTN: YUE WAH CHOW PHONE NO : 60 3 87061486
LOT 1, JALAN 3, SE DECISION MADE: 03-OCT-02
KAWASAN PERUSAHAAN BANDAR BARU 510(k) SUMMARY AVAILABLE FROM FDA
SALAK TINGGI, SEPANG SELANGOR, MALAYSIA 43900
DEVICE: DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K022808(TRADITIONAL)
ATTN: V. NADARAJAN PHONE NO : 603 870 69788
KAWASAN PERUSAHAAN SE DECISION MADE: 03-OCT-02
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: ELITE MONOPHASE
ZHERMACK S.P.A. 510(k) NO: K022653(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 28-OCT-02
BEND, OR 97702 510(k) STATEMENT
DEVICE: NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMOR
ZIMMER, INC. 510(k) NO: K023211(SPECIAL)
ATTN: STEPHEN H MCKELVEY PHONE NO : 574-372-4944
P.O. BOX 708 SE DECISION MADE: 17-OCT-02
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 333
TOTAL WITH SUMMARIES 257
TOTAL WITH STATEMENTS 76
Updated 4/28/2004
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