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510(k)s Final Decisions Rendered for May 2004 |
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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-MAY-2004 THROUGH 31-MAY-2004
DEVICE: MODIFICATION TO ADPER PROMPT
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K040857(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 10-MAY-04
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR
A & D ENGINEERING, INC. 510(k) NO: K040371(SPECIAL)
ATTN: JERRY WANG PHONE NO : 408-518-5113
1555 MCCANDLESS DR. SE DECISION MADE: 19-MAY-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREENLIGHT 300
A C COSSOR & SON (SURGICAL) LIMITE510(k) NO: K040410(TRADITIONAL)
ATTN: A J COSSOR PHONE NO : 440 208 8001172
VALE ROAD SE DECISION MADE: 05-MAY-04
LONDON, UNITED KINGDOM N4 1PS 510(k) STATEMENT
DEVICE: FOX PLUS PTA CATHETER
ABBOTT LABORATORIES INC 510(k) NO: K040954(SPECIAL)
ATTN: JOANNA KUSKOWSKI PHONE NO : 650-474-3331
800 SAGINAW DRIVE SE DECISION MADE: 11-MAY-04
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, ME
ACCU-STAT DIAGNOSTICS, INC. 510(k) NO: K040629(TRADITIONAL)
ATTN: JAMES G BARRONS PHONE NO : 949-916-7560
11 ORCHARD RD., SUITE 108 SE DECISION MADE: 05-MAY-04
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE
ACON LABORATORIES, INC. 510(k) NO: K040274(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 03-MAY-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROP
ACON LABORATORIES, INC. 510(k) NO: K040445(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 19-MAY-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI GAMMA CAMERA, MODEL MGC-500
ACRORAD COMPANY, LTD. 510(k) NO: K040587(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE ROAD SE DECISION MADE: 14-MAY-04
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIADUCT MINISCOPE AND ACCESSORIES
ACUEITY, INC. 510(k) NO: K040949(TRADITIONAL)
ATTN: NANCY LINCE PHONE NO : 650-759-6186
100 HAMILTON AVE., SUITE 140 SE DECISION MADE: 07-MAY-04
PALO ALTO, CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNTEGRA
ADAC LABORATORIES 510(k) NO: K041182(TRADITIONAL)
ATTN: JOY M SACMAR PHONE NO : 408-468-3053
540 ALDER DR. SE DECISION MADE: 21-MAY-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GRIFFIN SPECT/CT IMAGING SYSTEM
ADAC LABORATORIES 510(k) NO: K041218(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051
540 ALDER DR. SE DECISION MADE: 24-MAY-04
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KOLPEXIN SPHERE
ADAMED LTD. 510(k) NO: K032644(TRADITIONAL)
ATTN: NORMAN I BRUCKNER PHONE NO : 972-596-4151
3432 BROOKSHIRE DR. SE DECISION MADE: 28-MAY-04
PLANO, TX 75075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
AESCULAP, INC. 510(k) NO: K040017(SPECIAL)
ATTN: JONI L SWOVELAND PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 14-MAY-04
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESKULISA CARDIOLIPIN AGM
AESKU, INC 510(k) NO: K040463(TRADITIONAL)
ATTN: STANLEY AMMONS PHONE NO : 703-860-5057
8880 NORTHWEST 18TH TERRACE SE DECISION MADE: 12-MAY-04
MIAMI, FL 33172 510(k) STATEMENT
DEVICE: IMPAX OT3000 ORTHOPEDIC WORKSTATION
AGFA CORP. 510(k) NO: K040344(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 519 746 2900
455 PHILIP STREET SE DECISION MADE: 12-MAY-04
WATERLOO, ONTARIO, CANADA N2L 3X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPAX CLIENT EMBRACE
AGFA CORP. 510(k) NO: K040555(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 519 746 2900
455 PHILIP STREET SE DECISION MADE: 26-MAY-04
WATERLOO, ONTARIO, CANADA N2L 3X2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR SAFETY HEPA AND NON-HEPA FILTERS
AIR SAFETY LTD 510(k) NO: K033008(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 13-MAY-04
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
AKERS LABORATORIES, INC. 510(k) NO: K040293(TRADITIONAL)
ATTN: BARBARA A BAGBY PHONE NO : 609-848-8698
201 GROVE RD. SE DECISION MADE: 28-MAY-04
THOROFARE, NJ 08086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
ALM S.A. 510(k) NO: K040735(SPECIAL)
ATTN: FREDERICK R CATT PHONE NO : 585-272-5013
1777 EAST HENRIETTA ROAD SE DECISION MADE: 21-MAY-04
ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM
ALVEOLUS, INC. 510(k) NO: K033990(SPECIAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
401 NORTH TRYON ST. SE DECISION MADE: 12-MAY-04
10TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CHARLOTTE, NC 28202
DEVICE: AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
AMEDICA BIOTECH, INC. 510(k) NO: K040464(TRADITIONAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 17-MAY-04
HAYWARD, CA 94545 510(k) STATEMENT
DEVICE: AMS PERIGEE SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K040623(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-930-6000
10700 BREN RD., WEST SE DECISION MADE: 17-MAY-04
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150
ANALOGIC CORP. 510(k) NO: K040995(ABBREVIATED)
ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 25-MAY-04
PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APAPORE BONE GRAFT SUBSTITUTE
APATECH LTD. 510(k) NO: K033722(ABBREVIATED)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 07-MAY-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWTOM 3G QR-DVT 9000
APERIO SERVICES, LLC 510(k) NO: K041137(SPECIAL)
ATTN: K. ROBERT WISNER PHONE NO : 941-955-2885
950 S. TAMIAMI TRAIL, SE DECISION MADE: 14-MAY-04
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
SARASOTA, FL 34236
DEVICE: APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR
APPLE MEDICAL CORP. 510(k) NO: K041131(TRADITIONAL)
ATTN: JOHN C PULFORD PHONE NO : 508-357-2700
28 LORD RD., UNIT 135 SE DECISION MADE: 13-MAY-04
MARLBORO, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR,
APPLIED DIABETES RESEARCH, INC. 510(k) NO: K041152(SPECIAL)
ATTN: JIM BARLEY PHONE NO : 949-481-5713
PO BOX 3900 SE DECISION MADE: 24-MAY-04
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEP-TIP CHRONIC HEMODIALYSIS CATHETER
ARROW INTERNATIONAL, INC. 510(k) NO: K040666(TRADITIONAL)
ATTN: BRANDON EPTING PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 14-MAY-04
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA-AORTIC BALLOON (IAB)
ARROW INTL., INC. 510(k) NO: K040801(SPECIAL)
ATTN: WILLIAM PAQUIN PHONE NO : 617-389-6400
9 PLYMOUTH ST. SE DECISION MADE: 06-MAY-04
EVERETT, MA 02149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -1
ARTHREX, INC. 510(k) NO: K040381(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 12-MAY-04
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROTEK LACTONAIL
ARTHROTEK, INC. 510(k) NO: K040500(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 25-MAY-04
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI~NEB; OMNI~MAX
B & B MEDICAL TECHNOLOGIES, INC. 510(k) NO: K030396(TRADITIONAL)
ATTN: STEPHEN W BRIGGS PHONE NO : 916-331-5221
6731 32ND ST., SUITE A&B; SE DECISION MADE: 07-MAY-04
NORTH HIGHLANDS, CA 95660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC07
BAUSCH & LOMB, INC. 510(k) NO: K033854(TRADITIONAL)
ATTN: PAUL G STAPLETON PHONE NO : 585-338-8172
1400 NORTH GOODMAN ST. SE DECISION MADE: 19-MAY-04
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARADIGM LINK BLOOD GLUCOSE METER
BECTON DICKINSON & CO. 510(k) NO: K040603(TRADITIONAL)
ATTN: JOHN SCHALAGO PHONE NO : 201-847-5663
1 BECTON DR. SE DECISION MADE: 19-MAY-04
FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TR
BECTON DICKINSON & CO. 510(k) NO: K041071(SPECIAL)
ATTN: JING ZHANG PHONE NO : 201-847-4717
1 BECTON DRIVE SE DECISION MADE: 14-MAY-04
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TES
BECTON, DICKINSON & CO. 510(k) NO: K033458(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 28-MAY-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-
BECTON, DICKINSON & CO. 510(k) NO: K040716(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 14-MAY-04
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUICHEK TORCH PLUS IGM CONTROL
BIO-RAD LABORATORIES, INC. 510(k) NO: K040822(TRADITIONAL)
ATTN: MARIA KEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 19-MAY-04
IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITTLE GRAFTER SCREW
BIOCOMPOSITES LTD. 510(k) NO: K040265(TRADITIONAL)
ATTN: J. STEPHEN BRATT PHONE NO : 44 178 2206500
ETRUSCAN ST., ETRURIA SE DECISION MADE: 28-MAY-04
STOKE ON TRENT, UNITED KINGDOM ST1510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENEX BONE GRAFT SUBSTITUTE
BIOCOMPOSITES LTD. 510(k) NO: K040600(TRADITIONAL)
ATTN: J. STEPHEN BRATT PHONE NO : 44 178 2206500
ETRUSCAN ST. SE DECISION MADE: 07-MAY-04
ETRURIA 510(k) SUMMARY AVAILABLE FROM FDA
STOKE ON TRENT, STAFFORDSHIRE, UNITED KINGDOM ST1 5PQ
DEVICE: Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
BIOMEDIX, INC. 510(k) NO: K033627(TRADITIONAL)
ATTN: JUDY S CHEN PHONE NO : 510-438-9500
40471 ENCYCLOPEDIA CIRCLE SE DECISION MADE: 21-MAY-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMAX SUTURE ANCHOR
BIOMET, INC. 510(k) NO: K040475(TRADITIONAL)
ATTN: KACY ARNOLD PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 21-MAY-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: MAXIM ACCEL (VANGUARD) PS+ BEARINGS
BIOMET, INC. 510(k) NO: K041046(SPECIAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 21-MAY-04
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: BIOTOP DJT-A SAFETY SYRINGE
BIOTOP TECHNOLOGY CO., LTD. 510(k) NO: K032747(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
58 FU-CHIUN STREET SE DECISION MADE: 11-MAY-04
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAXCEL PLUS CHRONIC DIALYSIS CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K040736(TRADITIONAL)
ATTN: NICHOLAS CONDAKES PHONE NO : 508-652-5003
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 18-MAY-04
NATICK, MA 01760-1573 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY CORE BIOPSY SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K040893(SPECIAL)
ATTN: CHRISTINE M CAMERON PHONE NO : 508-650-8471
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 06-MAY-04
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TABLE TILT DEVICE
BRAINLAB AG 510(k) NO: K033316(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 999 15680
AMMERTHALSTRASSE 8 SE DECISION MADE: 14-MAY-04
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
BRAINLAB AG 510(k) NO: K040585(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 11-MAY-04
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
C.R. BARD, INC. 510(k) NO: K040504(TRADITIONAL)
ATTN: JOHN C KNORPP PHONE NO : 770-784-6451
8195 INDUSTRIAL BLVD. SE DECISION MADE: 14-MAY-04
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOA III ENTERAL NUTRITION PUMP
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K040957(TRADITIONAL)
ATTN: GALI TZURY PHONE NO : 972 4 6271737
16 SHACHAM STREET SE DECISION MADE: 21-MAY-04
INDUSTRIAL PARK 510(k) STATEMENT
CAESAREA, ISRAEL 38900
DEVICE: LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
CARDINAL HEALTH 510(k) NO: K033789(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 07-MAY-04
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONE CEMENT FOR CRANIOPLASTY
CARDINAL HEALTH 510(k) NO: K040152(TRADITIONAL)
ATTN: SHARON NICHOLS PHONE NO : 847-785-3311
1500 WAUKEGAN RD. SE DECISION MADE: 19-MAY-04
BLDG. WM 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085
DEVICE: CHAD THERAPEUTICS SAGE
CHAD THERAPEUTICS, INC. 510(k) NO: K033364(TRADITIONAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883
21622 PLUMMER ST. SE DECISION MADE: 11-MAY-04
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Z LUBRICATING JELLY
CHESTER LABS, INC. 510(k) NO: K041060(TRADITIONAL)
ATTN: JOHN B ARMSTRONG PHONE NO : 513-458-3840
1900 SECTION RD. SE DECISION MADE: 07-MAY-04
CINCINNATI, OH 45237 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS
CLARUS MEDICAL, LLC. 510(k) NO: K040424(TRADITIONAL)
ATTN: TOM BARTHEL PHONE NO : 763-525-8403
1000 BOONE AVE. NORTH SE DECISION MADE: 11-MAY-04
MINNEAPOLIS, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALAB IRON REAGENT
CLINICAL DATA, INC. 510(k) NO: K033983(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 W. LAMBERT ROAD SE DECISION MADE: 21-MAY-04
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821 THIRD PARTY REVIEW
DEVICE: LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS
CLINIQA CORPORATION 510(k) NO: K040927(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 17-MAY-04
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: ENDOTINE TRANSBLEPH DEVICE
COAPT SYSTEMS, INC. 510(k) NO: K040740(TRADITIONAL)
ATTN: LORI DONDIEGO PHONE NO : 650-461-7647
1820 EMBARCADERO RD. SE DECISION MADE: 10-MAY-04
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN WOUND DRESSING - ORAL
COLLAGEN MATRIX, INC. 510(k) NO: K040403(TRADITIONAL)
ATTN: PEGGY HANSEN PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 10-MAY-04
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
COLOPLAST CORP. 510(k) NO: K033869(TRADITIONAL)
ATTN: ELIZABETH BOOTS PHONE NO : 507-386-4362
1940 COMMERCE DR. SE DECISION MADE: 17-MAY-04
NORTH MANKATO, MN 56003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL TEMP NATURAL
COLTENE AG 510(k) NO: K041098(TRADITIONAL)
ATTN: H.J. VOGELSTEIN PHONE NO : 212-289-4748
1349 LEXINGTON AVE. SE DECISION MADE: 13-MAY-04
NEW YORK, NY 10128 510(k) STATEMENT
DEVICE: COOLAN 300
COOLANALGESIA LTD. 510(k) NO: K030810(TRADITIONAL)
ATTN: PETER WILKINSON PHONE NO : 44 149 4581297
WILLIAM GATES BUILDING SE DECISION MADE: 05-MAY-04
15 J.J. THOMSON AVENUE 510(k) STATEMENT
CAMBRIDGE, ENGLAND, UNITED KINGDOMTHIRD PARTY REVIEW
DEVICE: CRADLE PACS
CRADLE TECHNOLOGY CORP. 510(k) NO: K033912(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 11-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
CROWN DELTA CORP. 510(k) NO: K041028(TRADITIONAL)
ATTN: MARK P KONOPKA PHONE NO : 914-245-8910
1550 FRONT ST. SE DECISION MADE: 14-MAY-04
YORKTOWN HEIGHTS, NY 10598 510(k) STATEMENT
DEVICE: CRYMED CRYO-ABLATOR
CRYMED TECHNOLOGIES, INC. 510(k) NO: K040809(TRADITIONAL)
ATTN: FRANK MAJEROWICZ PHONE NO : 410-252-3313
319 W. TIMONIUM RD. SE DECISION MADE: 21-MAY-04
LUTHERVILLE, MD 21093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
CRYOCOR, INC. 510(k) NO: K040552(TRADITIONAL)
ATTN: JAMI MILLER PHONE NO : 858-909-2200
9717 PACIFIC HEIGHTS BLVD. SE DECISION MADE: 28-MAY-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERICOR
CVP DIAGNOSTICS, INC. 510(k) NO: K031327(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE RD. SE DECISION MADE: 12-MAY-04
BROOKEVILLE, MD 20833 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOTOSILK PULSED LIGHT SYSTEM
CYNOSURE, INC. 510(k) NO: K041095(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 26-MAY-04
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DXL CALSCAN
DEMETECH AB 510(k) NO: K033550(TRADITIONAL)
ATTN: JOAKIM ARWIDSON PHONE NO : 468 555 79200
DALVAGEN 24 SE DECISION MADE: 05-MAY-04
SOLNA, SWEDEN 16956 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRITY TEMPORARY CEMENT
DENTSPLY INTL. 510(k) NO: K040895(TRADITIONAL)
ATTN: P. JEFFERY LEHN PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 21-MAY-04
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: BIOKNOTLESS RC ANCHOR
DEPUY MITEK 510(k) NO: K041064(SPECIAL)
ATTN: ALLYSON BARFORD PHONE NO : 781-251-2794
249 VANDERBILT DR. SE DECISION MADE: 13-MAY-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANALOK RC LOOP ANCHOR
DEPUY MITEK 510(k) NO: K041065(SPECIAL)
ATTN: ALLYSON BARFORD PHONE NO : 781-251-2794
249 VANDERBILT DR. SE DECISION MADE: 07-MAY-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPER QUICKANCHOR PLUS
DEPUY MITEK 510(k) NO: K041116(SPECIAL)
ATTN: ALLYSON BARFORD PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 28-MAY-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE P
DEPUY MITEK 510(k) NO: K041117(SPECIAL)
ATTN: ALLYSON BARFORD PHONE NO : 781-251-2700
249 VANDERBILT DR. SE DECISION MADE: 28-MAY-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GII QUICKANCHOR PLUS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041115(SPECIAL)
ATTN: ALLYSON BARFORD PHONE NO : 781-251-2794
249 VANDERBILT AVE. SE DECISION MADE: 28-MAY-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRO
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K041135(SPECIAL)
ATTN: RUTH C FORSTADT PHONE NO : 781-251-3188
249 VANDERBILT AVE. SE DECISION MADE: 10-MAY-04
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K033273(TRADITIONAL)
ATTN: NATALIE HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 06-MAY-04
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEPUY PRESERVATION UNICONDYLAR TIBIA
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K040268(SPECIAL)
ATTN: ABRAHAM WRIGHT PHONE NO : 574-372-7025
700 ORTHOPAEDIC DR. SE DECISION MADE: 05-MAY-04
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: TRIFLANGE II ACETABULAR CUP SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K040383(TRADITIONAL)
ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905
700 ORTHOPAEDIC DRIVE SE DECISION MADE: 12-MAY-04
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066
DEPUY, INC. 510(k) NO: K040544(TRADITIONAL)
ATTN: DINA L WEISSMAN PHONE NO : 574-371-4905
700 ORTHOPAEDIC DR. SE DECISION MADE: 28-MAY-04
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLI
DESIGN STANDARDS CORP. 510(k) NO: K040602(TRADITIONAL)
ATTN: MICHELE LUCEY PHONE NO : 603-826-7744
182 CEDA RD. SE DECISION MADE: 10-MAY-04
P.O. BOX 1620 510(k) SUMMARY AVAILABLE FROM FDA
CHARLESTOWN, NH 03603
DEVICE: D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
DIDECO S.P.A. 510(k) NO: K041061(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
195 WEST ST. SE DECISION MADE: 06-MAY-04
WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K040939(SPECIAL)
ATTN: YAEL RUBIN PHONE NO : 972 9 9511511
3 HASADNAOT ST. SE DECISION MADE: 12-MAY-04
HERZLIYA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DE
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K033957(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 14-MAY-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO INFINITY EXPLORER
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K040945(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 12-MAY-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY GAMMA
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K041087(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 12-MAY-04
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
DYMEDIX, INC. 510(k) NO: K040069(TRADITIONAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LN. SE DECISION MADE: 05-MAY-04
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NOMAD FROM DYNAMIS MOBILITY LTD.
DYNAMIS MOBILITY LTD. 510(k) NO: K040457(TRADITIONAL)
ATTN: RUTH LYTLE PHONE NO : 905 671 0249
2765 THAMESGATE DR. SE DECISION MADE: 19-MAY-04
MISSISSAUGA, ONTARIO, CANADA L4T 1510(k) STATEMENT
DEVICE: KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253
EASTMAN KODAK COMPANY 510(k) NO: K040378(TRADITIONAL)
ATTN: SUSAN PATE PHONE NO : 585-724-4302
343 STATE ST. SE DECISION MADE: 24-MAY-04
ROCHESTER, NY 14650-1131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOTRAX ULTRASONIC POCKET DOPPLER
EDAN INSTRUMENTS, INC. 510(k) NO: K040480(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200
1 ODELL PLAZA SE DECISION MADE: 25-MAY-04
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR LCD MONITOR, MODEL RADIFORCE R12
EIZO NANAO CORPORATION 510(k) NO: K040982(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 13-MAY-04
MATTO-SHI 510(k) STATEMENT
ISHIKAWA-KEN, JAPAN 924-8566
DEVICE: MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
ENCORE MEDICAL, L.P. 510(k) NO: K040397(SPECIAL)
ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-832-9500
9800 METRIC BLVD. SE DECISION MADE: 06-MAY-04
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENERTRON CPR JACK
ENERTRON ENGINEERING CO. 510(k) NO: K024215(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 14-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC
EPICOR MEDICAL, INC. 510(k) NO: K040641(TRADITIONAL)
ATTN: KATHI GUERRANT PHONE NO : 408-733-6500
240 SANTA ANA COURT SE DECISION MADE: 05-MAY-04
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTOSCAN C
ESAOTE S.P.A. 510(k) NO: K040877(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 04-MAY-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO E-SCAN XQ MRI SYSTEM
ESAOTE S.P.A. 510(k) NO: K041145(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 14-MAY-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOVIA CALCIUM PHOSPHATE CERAMIC
EUROSURGICAL S.A. 510(k) NO: K040514(TRADITIONAL)
ATTN: KAREN E WARDEN, MEBE PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 03-MAY-04
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
EXACTECH, INC. 510(k) NO: K032522(TRADITIONAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 28-MAY-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
EXACTECH, INC. 510(k) NO: K033596(TRADITIONAL)
ATTN: GARY MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 10-MAY-04
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER
EXERO PRODUCTS, INC. 510(k) NO: K040914(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 27-MAY-04
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K040506(TRADITIONAL)
ATTN: JAMES THOMPSON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 05-MAY-04
EAST TAMAKI, AUCKLAND, NEW ZEALAND510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L-TENS
FUJI DYNAMICS LIMITED 510(k) NO: K041164(TRADITIONAL)
ATTN: ANTHONY AH YIN, SHUM PHONE NO : 852 278 64218
UNIT 1-3, LAWS COMMERCIAL SE DECISION MADE: 20-MAY-04
PLAZA 788 CHEUNG SHA WAN RD. 510(k) SUMMARY AVAILABLE FROM FDA
HONG KONG, CHINA
DEVICE: FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR
FUKUDA DENSHI USA, INC. 510(k) NO: K040246(TRADITIONAL)
ATTN: LARRY D WALKER PHONE NO : 425-881-7737
17725 N.E. 65TH ST., BLDG. C SE DECISION MADE: 26-MAY-04
REDMOND, WA 98052-4911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE US
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K040255(SPECIAL)
ATTN: JEAN WILLEY PHONE NO : 303-231-4526
10810 W. COLLINS AVE. SE DECISION MADE: 24-MAY-04
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIQ ANALYSIS III
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K041267(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 27-MAY-04
W-400 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: CT COLONOGRAPHY II
GENERAL ELECTRIC MEDICAL SYSTEMS 510(k) NO: K041270(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 27-MAY-04
W-400 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: PROTEX STABILIZATION SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K040442(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LANE SE DECISION MADE: 20-MAY-04
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
GOLDEN TECHNOLOGIES, INC. 510(k) NO: K041025(SPECIAL)
ATTN: GENE R KULON PHONE NO : 800-624-6374
401 BRIDGE ST. SE DECISION MADE: 03-MAY-04
OLD FORGE, PA 18518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METACRYL
GREAT LAKES ORTHODONTICS, LTD. 510(k) NO: K040881(TRADITIONAL)
ATTN: MARK LAUREN PHONE NO : 716-871-1161
200 COOPER AVE. SE DECISION MADE: 25-MAY-04
P.O. BOX 5111 510(k) SUMMARY AVAILABLE FROM FDA
TONAWANDA, NY 14151-5111
DEVICE: HEARTSINE SAMARITAN PAD
HEARTSINE TECHNOLOGIES, INC. 510(k) NO: K041067(SPECIAL)
ATTN: WILLIAM J SMIRLES PHONE NO : 847-317-0926
940 CALLE AMANECER, SUITE E SE DECISION MADE: 25-MAY-04
SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINICAL LABORATORY ANALYZING SYSTEM
HEMOCUE, INC. 510(k) NO: K041230(SPECIAL)
ATTN: R.J. SLOMOFF PHONE NO : 301-983-1707
9229 CRANFORD DR. SE DECISION MADE: 20-MAY-04
POTOMAC, MD 20854 510(k) STATEMENT
DEVICE: REFOBACIN -PALACOS G
HERAEUS KULZER GMBH & CO. KG 510(k) NO: K031673(TRADITIONAL)
ATTN: K.-D. KUHN PHONE NO : 49 608 1959264
GRUNER WEG 11 SE DECISION MADE: 25-MAY-04
HANAU, GERMANY D-63450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERACERAM PRESS
HERAEUS KULZER, INC. 510(k) NO: K040859(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 S. LAFAYETTE BLVD. SE DECISION MADE: 20-MAY-04
SOUTH BEND, IN 46614 510(k) STATEMENT
DEVICE: RESTORE WOUND CLEANSER
HOLLISTER, INC. 510(k) NO: K040779(TRADITIONAL)
ATTN: JOSEPH S TOKARZ PHONE NO : 847-680-2849
2000 HOLLISTER DR. SE DECISION MADE: 17-MAY-04
LIBERTYVILLE, IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
HOWMEDICA OSTEONICS CORP 510(k) NO: K033971(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 28-MAY-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
HOWMEDICA OSTEONICS CORP 510(k) NO: K040267(TRADITIONAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
325 CORPORATE DR. SE DECISION MADE: 05-MAY-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
HOWMEDICA OSTEONICS CORP 510(k) NO: K040964(SPECIAL)
ATTN: KAREN ARIEMMA PHONE NO : 201-831-5718
325 CORPORATE DR. SE DECISION MADE: 28-MAY-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K041160(SPECIAL)
ATTN: MARGARET F CROWE PHONE NO : 201-831-5580
325 CORPORATE DRIVE SE DECISION MADE: 27-MAY-04
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
I-FLOW CORP. 510(k) NO: K040337(TRADITIONAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 24-MAY-04
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORSO ARRAY COIL, MODEL 558GE-64
IGC-MEDICAL ADVANCES, INC. 510(k) NO: K041185(TRADITIONAL)
ATTN: ANTHONY DIETZLER PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 14-MAY-04
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: I-TEC PORTABLE DENTAL OPERATORY
INDIGENOUS PEOPLES TECHNOLOGY AND 510(k) NO: K040153(TRADITIONAL)
ATTN: JESSE SAINT PHONE NO : 352-465-4545
10575 SW 147TH CIRCLE SE DECISION MADE: 21-MAY-04
DUNNELLON, FL 34432 510(k) STATEMENT
DEVICE: CELSIUS CONTROL SYSTEM
INNERCOOL THERAPIES, INC. 510(k) NO: K033623(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 858-713-9507
3931 SORRENTO VALLEY BLVD. SE DECISION MADE: 21-MAY-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INOGEN ONE OXYGEN CONCENTRATOR
INOGEN, INC. 510(k) NO: K032818(TRADITIONAL)
ATTN: JOHN WELLS PHONE NO : 805-562-0500
120 CREMONA DRIVE SE DECISION MADE: 13-MAY-04
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
GOLETA, CA 93117
DEVICE: RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT
INSTITUT STRAUMANN AG 510(k) NO: K041295(SPECIAL)
ATTN: JOHN KING PHONE NO : 800-448-8168
RESERVOIR PLACE SE DECISION MADE: 24-MAY-04
1601 TRAPELO ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02451
DEVICE: QUANTEX FERRITIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K040879(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 10-MAY-04
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
INTERLAB S.R.L. 510(k) NO: K040146(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 04-MAY-04
EAST STROUDSBURG, PA 18301-8804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR-THERM MICRO HME, MODEL 1441
INTERSURGICAL, INC. 510(k) NO: K032322(TRADITIONAL)
ATTN: MICHAEL ZALEWSKI PHONE NO : 315-451-2900
417 ELECTRONICS PKWY. SE DECISION MADE: 13-MAY-04
LIVERPOOL, NY 13088 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODE
INTUITIVE SURGICAL, INC. 510(k) NO: K040948(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2145
950 KIFER RD. SE DECISION MADE: 05-MAY-04
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
INVACARE CORPORATION 510(k) NO: K041072(TRADITIONAL)
ATTN: CARROLL L MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 12-MAY-04
ELYRIA, OH 44035-4190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
ISURGICAL 510(k) NO: K040639(TRADITIONAL)
ATTN: KEN LEISER PHONE NO : 847-949-9744
26625 COUNTRYSIDE LAKE DRIVE SE DECISION MADE: 21-MAY-04
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA
IVD RESEARCH, INC. 510(k) NO: K032897(TRADITIONAL)
ATTN: DAVE LAMBILLOTTE PHONE NO : 760-929-7744
5909 SEA LION PLACE, SUITE D SE DECISION MADE: 27-MAY-04
CARLSBAD, CA 92008 510(k) STATEMENT
DEVICE: MULTICORE HB; MULTICORE FLOW
IVOCLAR VIVADENT, INC. 510(k) NO: K040795(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-692-2260
175 PINEVIEW DR. SE DECISION MADE: 17-MAY-04
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: SR ADORO
IVOCLAR VIVADENT, INC. 510(k) NO: K040951(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 19-MAY-04
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JMS BYPASS TUBE
JMS NORTH AMERICA CORP. 510(k) NO: K032977(TRADITIONAL)
ATTN: SWEE C CHONG PHONE NO : 510-888-9090
22320 FOOTHILL BLVD., SE DECISION MADE: 25-MAY-04
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
HAYWARD, CA 94541
DEVICE: NEXT GENERATION SALEM SUMP
KENDALL 510(k) NO: K040388(TRADITIONAL)
ATTN: JIM WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 17-MAY-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR
KENDALL 510(k) NO: K041006(SPECIAL)
ATTN: JAMES WELSH PHONE NO : 508-261-8532
15 HAMPSHIRE ST. SE DECISION MADE: 19-MAY-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINSPIRATION SYSTEM
KERBEROS PROXIMAL SOLUTIONS, INC. 510(k) NO: K041291(SPECIAL)
ATTN: TOM MASON PHONE NO : 650-254-1005
1400 TERRA BELLA AVE, SUITE K SE DECISION MADE: 21-MAY-04
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNE
KING SYSTEMS CORP. 510(k) NO: K033189(SPECIAL)
ATTN: TOM MCGRAIL PHONE NO : 800-642-5464
15011 HERRIMAN BLVD. SE DECISION MADE: 04-MAY-04
NOBLESVILLE, IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBI SELF PROPELLED SHOWER COMMODE
KJAERULFF REHABILITATION A/S 510(k) NO: K040677(TRADITIONAL)
ATTN: PHILIP L HARRIS PHONE NO : 45 638 21532
ORKEBYVEJ 6 SE DECISION MADE: 20-MAY-04
OTTERUP, DENMARK DK-5450 510(k) STATEMENT
DEVICE: KLS MARTIN HAND PLATING SYSTEM
KLS-MARTIN L.P. 510(k) NO: K040598(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHN'S IND. PKWY. SE DECISION MADE: 13-MAY-04
SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
KLS-MARTIN L.P. 510(k) NO: K040891(TRADITIONAL)
ATTN: JENNIFER DAMATO PHONE NO : 904-641-7746
11239-1 ST. JOHNS INDUSTRIAL SE DECISION MADE: 28-MAY-04
PARKWAY SOUTH 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32246
DEVICE: LAKE REGION HYDROPHILIC GUIDEWIRE
LAKE REGION MFG., INC. 510(k) NO: K040825(TRADITIONAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 17-MAY-04
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
LEDA CO., LTD. 510(k) NO: K040936(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301 K STREET, NW SE DECISION MADE: 03-MAY-04
SUITE 1100, EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005-3373
DEVICE: LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION
LIFESTREAM TECHNOLOGIES, INC. 510(k) NO: K033899(SPECIAL)
ATTN: JACKSON CONNOLLY PHONE NO : 208-457-9409
510 CLEARWATER LOOP, SUITE 101 SE DECISION MADE: 20-MAY-04
POST FALLS, ID 83854 510(k) STATEMENT
DEVICE: BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K033885(TRADITIONAL)
ATTN: CHENG-I LIN, PH.D. PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 19-MAY-04
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025
LINVATEC BIOMATERIALS, INC. 510(k) NO: K032894(TRADITIONAL)
ATTN: TUIJA ANNALA PHONE NO : 358 331 65600
P.O. BOX 3 SE DECISION MADE: 07-MAY-04
HERMIANKATU 6-8L 510(k) SUMMARY AVAILABLE FROM FDA
TAMPERE, FINLAND FIN-33720
DEVICE: SIMPLANT SYSTEM
MATERIALISE N.V. 510(k) NO: K033849(TRADITIONAL)
ATTN: CARL VAN LIERDE PHONE NO : 32 16 396611
15 TECHNOLOGIELAAN SE DECISION MADE: 25-MAY-04
LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBREX CATHETER PATENCY DEVICE
MEDICAL DEVICE TECHNOLOGIES, INC. 510(k) NO: K040427(TRADITIONAL)
ATTN: KARL SWARTZ PHONE NO : 352-338-0440
3600 SW 47TH AVENUE SE DECISION MADE: 03-MAY-04
GAINESVILLE, FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INOGEN SATELLITE CONSERVER
MEDICAL ELECTRONIC DEVICES, INC. 510(k) NO: K033197(TRADITIONAL)
ATTN: THOMAS WENZEL PHONE NO : 310-618-0366
2807 OREGON CT. #D6 SE DECISION MADE: 13-MAY-04
TORRANCE, CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
MEDICAL INDUSTRIES AMERICA, INC. 510(k) NO: K032170(TRADITIONAL)
ATTN: ANNE B CARLSON PHONE NO : 515-993-5001
2636 289TH PLACE SE DECISION MADE: 28-MAY-04
ADEL, IA 50003-8021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ECONOLITH E3000, MODEL 3000 (SW-6)
MEDISPEC, LTD. 510(k) NO: K040461(SPECIAL)
ATTN: SHERYL D SKINNER PHONE NO : 301-944-1575
12850 MIDDLEBROOK RD. STE. 1 SE DECISION MADE: 25-MAY-04
GERMANTOWN, MD 20874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDLINE STRIDER MINI 3
MEDLINE INDUSTRIES, INC. 510(k) NO: K040818(TRADITIONAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759
ONE MEDLINE PLACE SE DECISION MADE: 07-MAY-04
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDLINE STRIDER MINI 4
MEDLINE INDUSTRIES, INC. 510(k) NO: K040838(TRADITIONAL)
ATTN: MARGARET STEPHENS PHONE NO : 847-949-2277
ONE MEDLINE PLACE SE DECISION MADE: 07-MAY-04
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDLINE STRIDER MICRO 3
MEDLINE INDUSTRIES, INC. 510(k) NO: K041053(TRADITIONAL)
ATTN: MARGARET STEPHENS PHONE NO : 847-949-2277
ONE MEDLINE PLACE SE DECISION MADE: 25-MAY-04
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDLINE STRIDER MAXI 3
MEDLINE INDUSTRIES, INC. 510(k) NO: K041054(TRADITIONAL)
ATTN: ANDREA HAFERKAMP PHONE NO : 847-837-2759
ONE MEDLINE PLACE SE DECISION MADE: 25-MAY-04
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDL
MEDSAFE TECHNOLOGIES LLC. 510(k) NO: K032517(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 18-MAY-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-
MEDTRONIC MINIMED 510(k) NO: K040676(TRADITIONAL)
ATTN: MIRIELLE MENGOTTO PHONE NO : 818-576-4112
18000 DEVONSHIRE ST. SE DECISION MADE: 21-MAY-04
NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K040536(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 05-MAY-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K040962(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 14-MAY-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K041118(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 28-MAY-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BONE GRAFT WASHER
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K041217(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 28-MAY-04
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSXCHANGE SUPPORT CATHETER
MEDTRONIC VASCULAR 510(k) NO: K033540(TRADITIONAL)
ATTN: LEISA MARTINEZ PHONE NO : 707-541-3259
3576 UNOCAL PL. SE DECISION MADE: 25-MAY-04
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOY PATIENT MONITOR
MENNEN MEDICAL LTD. 510(k) NO: K024245(TRADITIONAL)
ATTN: ASHER KASSEL PHONE NO : 972 8 9323333
4 HAYARDEN ST., YAVNE SE DECISION MADE: 10-MAY-04
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
MESURE TECHNOLOGY CO.,LTD. 510(k) NO: K041056(SPECIAL)
ATTN: ROGER LU PHONE NO : 886 2 85122747
7F, 88, SEC. 1, KWANG FU ROAD SE DECISION MADE: 12-MAY-04
SAN CHUNG CITY 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) R.O.C.
DEVICE: MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
MICRO DIRECT, INC. 510(k) NO: K033688(TRADITIONAL)
ATTN: DAVID STASZAK PHONE NO : 207-786-7808
803 WEBSTER ST. SE DECISION MADE: 19-MAY-04
LEWISTON, ME 04240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M2 COMPATIBLE MICROKERATOME BLADE
MICRO SPECIALTIES, INC. 510(k) NO: K033457(TRADITIONAL)
ATTN: LEIGH S AYRES PHONE NO : 203-874-1832
264 QUARRY ROAD SE DECISION MADE: 25-MAY-04
MILFORD, CT 06460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI OXYCODONE ASSAY
MICROGENICS CORP. 510(k) NO: K040411(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 510-979-5012
46360 FREMONT BLVD. SE DECISION MADE: 27-MAY-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
MICROGENICS CORP. 510(k) NO: K040758(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 510-979-5012
46360 FREMONT BLVD. SE DECISION MADE: 28-MAY-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCUMENT SALICYLATE CAL VER
MICROGENICS CORP. 510(k) NO: K041073(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 510-979-5012
46360 FREMONT BLVD. SE DECISION MADE: 21-MAY-04
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYS
MISONIX, INC. 510(k) NO: K041058(TRADITIONAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 17-MAY-04
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VUE 100 ULTRASOUND IMAGING SYSTEM
MOBILSONIC, INC. 510(k) NO: K040652(TRADITIONAL)
ATTN: BAO LE PHONE NO : 408-892-4309
560 PARROTT STREET SE DECISION MADE: 17-MAY-04
SAN JOSE, CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K032965(TRADITIONAL)
ATTN: DAVID LOU PHONE NO : 852 242 09068
5/F GOLD KING IND. BLDG. 35 SE DECISION MADE: 13-MAY-04
TAI LIN PAI ROAD 510(k) STATEMENT
KWAI CHUNG N.T., HONG KONG
DEVICE: SUCTION COAGULATOR
MODERN MEDICAL EQUIPMENT MFG., LTD510(k) NO: K033003(TRADITIONAL)
ATTN: DAVID LOU PHONE NO : 852 242 09068
TAI LIN PAI RD. SE DECISION MADE: 13-MAY-04
KWAI CHUNG, HONG KONG, CHINA 510(k) STATEMENT
DEVICE: Y2K2 ENTERNAL FEEDING MANAGER
MOSS MEDICAL PRODUCTS 510(k) NO: K030413(TRADITIONAL)
ATTN: GERALD MOSS PHONE NO : 914-997-0392
1 REYNAL RD. SE DECISION MADE: 11-MAY-04
WHITE PLAINS, NY 10605 510(k) STATEMENT
DEVICE: SMARTLANK WIRELESS, MODEL 001970
MRL, A WELCH ALLYN COMPANY 510(k) NO: K033642(TRADITIONAL)
ATTN: DAVID KLEMENTOWSKI PHONE NO : 315-685-4133
4341 STATE STREET ROAD SE DECISION MADE: 25-MAY-04
SKANEATELES FALLS, NY 13153 510(k) STATEMENT
DEVICE: MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
MYTECH TECHNOLOGY CO., LTD. 510(k) NO: K041228(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 17-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERED WHEELCHAIR
NATS CORP. 510(k) NO: K033142(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT RD. SE DECISION MADE: 19-MAY-04
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: COMPRESSION ANASTOMOSIS CLIP (CAC)
NITI MEDICAL TECHNOLOGIES LTD. 510(k) NO: K033324(TRADITIONAL)
ATTN: ORLY MAOR PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 10-MAY-04
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-105
NOBEL BIOCARE AB 510(k) NO: K041236(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 26-MAY-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA BRIDGE ZIRCONIA
NOBEL BIOCARE AB 510(k) NO: K041283(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 28-MAY-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCERA ABUTMENT OCTAGON
NOBEL BIOCARE USA, INC. 510(k) NO: K041275(TRADITIONAL)
ATTN: ELIZABETH J MASON PHONE NO : 714-282-4800
22715 SAVI RANCH PKWY. SE DECISION MADE: 27-MAY-04
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NVISION DATA MANAGEMENT SOFTWARE
NONIN MEDICAL, INC. 510(k) NO: K033307(TRADITIONAL)
ATTN: JOHN R DALPEE PHONE NO : 763-553-9968
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 06-MAY-04
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
NORSELD PTY., LTD. 510(k) NO: K032397(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY RD. SE DECISION MADE: 27-MAY-04
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS
NOVA BIOMEDICAL CORP. 510(k) NO: K041016(TRADITIONAL)
ATTN: PAUL W MACDONALD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 07-MAY-04
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: NUMED MULLINS X PTA CATHETER
NUMED, INC. 510(k) NO: K041093(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 06-MAY-04
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO NXSTAGE SYSTEM ONE
NXSTAGE MEDICAL, INC. 510(k) NO: K040696(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 26-MAY-04
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004
OMNILIGHT, INC. 510(k) NO: K040664(TRADITIONAL)
ATTN: RICK MURDOCK PHONE NO : 800-690-8070
45 DUSTY TRAIL DRIVE SE DECISION MADE: 28-MAY-04
PLACITAS,, NM 87043 510(k) STATEMENT
DEVICE: MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
ORBUS MEDICAL TECHNOLOGIES 510(k) NO: K041032(SPECIAL)
ATTN: DAVID L CAMP PHONE NO : 954-730-0711
5363 N.W. 35TH AVE. SE DECISION MADE: 10-MAY-04
FT. LAUDERDALE, FL 33309-6315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARIS 2004 CAPNOGRAPH
ORIDION LTD. 510(k) NO: K040011(SPECIAL)
ATTN: DOMINIC CORSALE PHONE NO : 781-453-0500
21 HIGHLAND CIRCLE SE DECISION MADE: 13-MAY-04
NEEDHAM, MA 02494-3038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K040225(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 06-MAY-04
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: STIMULONG PLUS CATHETER SET MODEL, VARIOUS
PAJUNK GMBH 510(k) NO: K033018(TRADITIONAL)
ATTN: BURK A BRANDT PHONE NO : 541-752-3953
5010 NW CRESCENT VALLEY DR. SE DECISION MADE: 05-MAY-04
CORVALLIS, OR 97330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EFLOW ELECTRONIC INHALER/NEBULIZER
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K033833(TRADITIONAL)
ATTN: LAWRENCE WEINSTEIN PHONE NO : 804-639-7235
2943 OAKLAKE BLVD. SE DECISION MADE: 05-MAY-04
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SLIP UROLOGY CATHETER
PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K040519(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET, NW SE DECISION MADE: 20-MAY-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIP UROLOGY INTRODUCER SHEATH
PERCUTANEOUS SYSTEMS, INC. 510(k) NO: K040520(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET, NW SE DECISION MADE: 20-MAY-04
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
PHAMATECH INC. 510(k) NO: K040575(TRADITIONAL)
ATTN: CARL MONGIOVI PHONE NO : 858-643-5555
10151 BARNES CANYON ROAD SE DECISION MADE: 20-MAY-04
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 1879
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K040449(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
DIAGNOSTICS DIVISION SE DECISION MADE: 11-MAY-04
MUNZINGER STRASSE 7 510(k) SUMMARY AVAILABLE FROM FDA
FREIBURG, GERMANY D-79111
DEVICE: VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 1899
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K040450(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
DIAGNOSTICS DIVISION SE DECISION MADE: 11-MAY-04
MUNZINGER STRASSE 7 510(k) SUMMARY AVAILABLE FROM FDA
FREIBURG, GERMANY D-79111
DEVICE: VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 1889
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K040451(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
DIAGNOSTICS DIVISION SE DECISION MADE: 11-MAY-04
MUNZINGER STRASSE 7 510(k) SUMMARY AVAILABLE FROM FDA
FREIBURG, GERMANY D-79111
DEVICE: VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 1
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K040452(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
DIAGNOSTICS DIVISION SE DECISION MADE: 11-MAY-04
MUNZINGER STRASSE 7 510(k) SUMMARY AVAILABLE FROM FDA
FREIBURG, GERMANY D-79111
DEVICE: VARELISA HISTONE ANTIBODIES, MODEL 16496
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K040810(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
DIAGNOSTICS DIVISION SE DECISION MADE: 14-MAY-04
MUNZINGER STRASSE 7 510(k) SUMMARY AVAILABLE FROM FDA
FREIBURG, GERMANY D-79111
DEVICE: VARELISA SSDNA ANTIBODIES, MODEL 14896
PHARMACIA DEUTSCHLAND GMBH 510(k) NO: K040811(TRADITIONAL)
ATTN: MICHAEL LINSS PHONE NO : 49 761 47805310
DIAGNOSTICS DIVISION SE DECISION MADE: 13-MAY-04
MUNZINGER STRASSE 7 510(k) SUMMARY AVAILABLE FROM FDA
FREIBURG, GERMANY D-79111
DEVICE: HEARTSTART MRX, MODEL M3535A
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K040404(TRADITIONAL)
ATTN: PETER OHANIAN PHONE NO : 978-659-3397
3000 MINUTEMAN RD. MS 0222 SE DECISION MADE: 04-MAY-04
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND I
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K040955(SPECIAL)
ATTN: DAVID OSBORN PHONE NO : 978-659-3178
3000 MINUTEMAN RD. SE DECISION MADE: 12-MAY-04
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
PHOTOMEDEX, INC. 510(k) NO: K040294(TRADITIONAL)
ATTN: BOB ROSE PHONE NO : 215-619-3600
147 KEYSTONE DRIVE SE DECISION MADE: 05-MAY-04
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER
PNEUPAC LTD. 510(k) NO: K040090(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 414-542-3100
N7 W22025 JOHNSON ROAD SE DECISION MADE: 27-MAY-04
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG
POSSIS MEDICAL, INC. 510(k) NO: K031357(TRADITIONAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 18-MAY-04
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY AN
POSSIS MEDICAL, INC. 510(k) NO: K040013(TRADITIONAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 18-MAY-04
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO WALKER ML-300 FOLDABLE WHEELCHAIR
PRO WALKER INC. 510(k) NO: K041337(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU, CHIUN ST. SE DECISION MADE: 28-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
PROCTER & GAMBLE CO. 510(k) NO: K040312(TRADITIONAL)
ATTN: MARK M ANDERSON PHONE NO : 513-634-5196
6110 CENTER HILL AVE. SE DECISION MADE: 03-MAY-04
CINCINNATI, OH 45224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOSPHOPLASTIN RL
R2 DIAGNOSTICS, INC. 510(k) NO: K040296(TRADITIONAL)
ATTN: PEGGY S CARTER PHONE NO : 574-288-4377
412 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 24-MAY-04
SOUTH BEND, IN 46601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX AMPHETAMINE CLASS ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K040350(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 12-MAY-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RANDOX METHADONE ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K040570(TRADITIONAL)
ATTN: PAULINE ARMSTRONG PHONE NO : 440 28 94422413
55 DIAMOND RD. SE DECISION MADE: 10-MAY-04
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
RAPID AID LTD. 510(k) NO: K040856(TRADITIONAL)
ATTN: ANNA OLASZ PHONE NO : 905 820 4788
4120 A SLADEVIEW CRESENT SE DECISION MADE: 03-MAY-04
MISSISSAUGA, ONTARIO, CANADA L5L 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-70
RAPID DIAGNOSTICS, INC. 510(k) NO: K033566(TRADITIONAL)
ATTN: ROBIN J HELLEN PHONE NO : 818-709-5646
9418 LASAINE AVE. SE DECISION MADE: 17-MAY-04
NORTHRIDGE, CA 91325 510(k) STATEMENT
DEVICE: MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K032914(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402-593-0781
8607 PARK DR. SE DECISION MADE: 25-MAY-04
OMAHA, NE 68127 510(k) STATEMENT
DEVICE: RESCAN
RESMED LTD. 510(k) NO: K034033(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 05-MAY-04
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL 509M PULSE OXIMETER, MODEL 509M
RESPIRONICS NOVAMETRIX, INC. 510(k) NO: K032755(TRADITIONAL)
ATTN: MICHAEL MALIS PHONE NO : 203-697-6442
5 TECHNOLOGY DR. SE DECISION MADE: 21-MAY-04
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARDUST II, MODEL 1011176
RESPIRONICS, INC. 510(k) NO: K021845(TRADITIONAL)
ATTN: ZITA YURKO PHONE NO : 724-733-0200
1001 MURRY RIDGE LN. SE DECISION MADE: 20-MAY-04
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
RESPIRONICS, INC. 510(k) NO: K041010(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 05-MAY-04
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAMP TROPONIN I ASSAY
RESPONSE BIOMEDICAL CORP. 510(k) NO: K033745(TRADITIONAL)
ATTN: WILLIAM J RADVAK PHONE NO : 604 681 4101
8081 LOUGHEED HWY. SE DECISION MADE: 17-MAY-04
BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAMP CK-MB ASSAY
RESPONSE BIOMEDICAL CORP. 510(k) NO: K033747(TRADITIONAL)
ATTN: WILLIAM J RADVAK PHONE NO : 604 681 4101
8081 LOUGHEED HWY. SE DECISION MADE: 17-MAY-04
BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RICH-MAR AUTOPRISM INFRARED LAMP
RICH-MAR CORP. 510(k) NO: K040679(TRADITIONAL)
ATTN: DAVID RICHARDS PHONE NO : 918-543-2222
15499 EAST 590TH RD. SE DECISION MADE: 07-MAY-04
P.O. BOX 879 510(k) STATEMENT
INOLA, OK 74036-0879
DEVICE: BILIRUBIN ASSAY ON THE OMNI S ANALYZER
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040174(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
9115 HAGUE ROAD SE DECISION MADE: 14-MAY-04
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS TROPONIN T STAT TEST
ROCHE DIAGNOSTICS CORP. 510(k) NO: K040733(TRADITIONAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 17-MAY-04
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIP
ROCHE DIAGNOSTICS CORP. 510(k) NO: K041227(SPECIAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 27-MAY-04
PO BOX 50457 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46250-0457
DEVICE: PH BUFFERING PLASTIC APPLICATOR TAMPON
ROSTAM LTD. 510(k) NO: K030474(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH ST. NW SE DECISION MADE: 28-MAY-04
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BITESTRIP
S.L.P. LTD. 510(k) NO: K030869(TRADITIONAL)
ATTN: TAMAR SHOCHAT PHONE NO : 972 3 5371281
18 HAZFIRA ST. SE DECISION MADE: 14-MAY-04
TEL-AVIV, ISRAEL 67779 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFILL BONE VOID FILLER
SCIENT'X 510(k) NO: K040454(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 07-MAY-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D
SECTRA-IMTEC AB 510(k) NO: K040376(SPECIAL)
ATTN: CARL ALLETTO PHONE NO : 214-262-4209
1600 MANCHESTER WAY SE DECISION MADE: 04-MAY-04
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR
SEIN ELECTRONICS CO., LTD. 510(k) NO: K032927(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DRIVE SE DECISION MADE: 07-MAY-04
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
SHIMADZU CORP. 510(k) NO: K040870(TRADITIONAL)
ATTN: TAKESHI OZAKI PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 17-MAY-04
TORRANCE, CA 90502-1328 510(k) STATEMENT
DEVICE: POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVE
SHUN THAI RUBBER GLOVES INDUSTRY P510(k) NO: K040406(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 14-MAY-04
SPARKS, NV 89434 510(k) STATEMENT
DEVICE: SIEMENS ENHANCED IMAGING SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K041166(TRADITIONAL)
ATTN: FRANK POKROP PHONE NO : 847-304-7516
2501 NORTH BARRINGTON RD. SE DECISION MADE: 17-MAY-04
HOFFMAN ESTATES, IL 60195-7372 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
SMITH & NEPHEW, INC. 510(k) NO: K040656(TRADITIONAL)
ATTN: JANET AKIL PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 25-MAY-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIGEN ADOLESCENT TAN
SMITH & NEPHEW, INC. 510(k) NO: K040929(TRADITIONAL)
ATTN: KIM KELLY PHONE NO : 901-399-6566
1450 E. BROOKS RD. SE DECISION MADE: 25-MAY-04
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE MET
SMITHS MEDICAL MD, INC. 510(k) NO: K031738(TRADITIONAL)
ATTN: RUSS DAVIES PHONE NO : 651-633-2556
1265 GREY FOX ROAD SE DECISION MADE: 27-MAY-04
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESE
SMITHS MEDICAL MD, INC. 510(k) NO: K040636(TRADITIONAL)
ATTN: PATRICIA A LAFORTE PHONE NO : 651-628-7267
1265 GREY FOX RD. SE DECISION MADE: 19-MAY-04
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
SOFRADIM PRODUCTION 510(k) NO: K041176(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 17-MAY-04
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL CONCEPTS INC. CODA
SPINAL CONCEPTS, INC. 510(k) NO: K033663(TRADITIONAL)
ATTN: LISA PETERSON PHONE NO : 512-533-1080
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 27-MAY-04
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
SPS MEDICAL SUPPLY CORP. 510(k) NO: K041099(SPECIAL)
ATTN: GARY J SOCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 06-MAY-04
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-SCORT...JR QUICKDRAW, MODEL 2400
SSCOR 510(k) NO: K041154(TRADITIONAL)
ATTN: SAM D SAY PHONE NO : 818-504-4054
11064 RANDALL ST. SE DECISION MADE: 18-MAY-04
SUN VALLEY, CA 91352 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH L
ST. JUDE MEDICAL 510(k) NO: K040165(TRADITIONAL)
ATTN: GLENN JACQUES PHONE NO : 952-238-9356
14901 DEVEAU PLACE SE DECISION MADE: 12-MAY-04
MINNETONKA, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STANDARD IMAGING E.IMRT CALCULATOR
STANDARD IMAGING, INC. 510(k) NO: K040688(TRADITIONAL)
ATTN: RAYMOND T RIDDLE PHONE NO : 608-831-0025
7601 MURPHY DR. SE DECISION MADE: 11-MAY-04
MIDDLETON, WI 53562-2766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLEX X
STRYKER CORP. 510(k) NO: K032945(TRADITIONAL)
ATTN: DANNIELLE WHEELER PHONE NO : 269-323-7700
4100 E. MILHAM AVE. SE DECISION MADE: 25-MAY-04
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K040390(TRADITIONAL)
ATTN: CHRISTOPHER L COOK PHONE NO : 408-754-2288
5900 OPTICAL CT. SE DECISION MADE: 17-MAY-04
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIDENT "T" ACETABULAR SHELLS
STRYKER ORTHOPAEDICS 510(k) NO: K040412(TRADITIONAL)
ATTN: GINNY STAMBERGER PHONE NO : 201-831-5467
325 CORPORATE DRIVE SE DECISION MADE: 25-MAY-04
MAHWAH, NJ 07432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONODERM
SURGICAL SPECIALTIES CORP. 510(k) NO: K040477(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 18-MAY-04
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 2.4 MM LCP WRIST PLATE
SYNTHES (USA) 510(k) NO: K040588(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
P.O. BOX 1766 SE DECISION MADE: 07-MAY-04
1690 RUSSELL ROAD 510(k) SUMMARY AVAILABLE FROM FDA
PAOLI, PA 19301-1222
DEVICE: RTA MODEL D RETINAL THICKNESS ANALYZER
TALIA TECHNOLOGY LTD. 510(k) NO: K041290(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST. N.W. SE DECISION MADE: 24-MAY-04
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMYLASE LIQUID REAGENT, MODEL A532-200
TECO DIAGNOSTICS 510(k) NO: K040920(SPECIAL)
ATTN: JIAN VAECHES PHONE NO : 714-693-7788
1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 10-MAY-04
ANAHEIM, CA 92807 510(k) STATEMENT
DEVICE: CERAFORM BONE VOID FILLER
TEKNIMED SA 510(k) NO: K040669(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 03-MAY-04
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENOJECT LUER ADAPTER
TERUMO EUROPE N.V. 510(k) NO: K041358(TRADITIONAL)
ATTN: SANDI HARTKA PHONE NO : 410-392-7243
125 BLUE BALL ROAD SE DECISION MADE: 28-MAY-04
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "BZ-576" NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR
THE BUZZ GROUP, LLC 510(k) NO: K033216(ABBREVIATED)
ATTN: DANIEL KAMM, P.E. PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 04-MAY-04
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN GRANULES
THE STRAUMANN CO. 510(k) NO: K040646(TRADITIONAL)
ATTN: LINDA JALBERT PHONE NO : 781-890-0001
RESERVOIR PL. 1601 TRAPELO RD. SE DECISION MADE: 03-MAY-04
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS REVERSED SHOULDER PROSTHESIS
TORNIER S.A. 510(k) NO: K030941(TRADITIONAL)
ATTN: DONALD F GRABARZ PHONE NO : 801-233-0075
7651 S. 700 WEST SE DECISION MADE: 14-MAY-04
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
SALT LAKE CITY, UT 84047-7101
DEVICE: DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR, MODEL DFP80
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K041027(TRADITIONAL)
ATTN: MICHAELA MAHL PHONE NO : 714-730-5000
2441 MICHELLE DRIVE SE DECISION MADE: 14-MAY-04
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
TYCO HEALTHCARE/KENDALL 510(k) NO: K040196(TRADITIONAL)
ATTN: BRIDGET GARDNER PHONE NO : 508-261-6384
15 HAMPSHIRE STREET SE DECISION MADE: 05-MAY-04
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
TZ MEDICAL, INC. 510(k) NO: K040208(TRADITIONAL)
ATTN: MADALYN DUNCAN PHONE NO : 503-639-0282
7272 S.W. DURHAM RD., #800 SE DECISION MADE: 11-MAY-04
PORTLAND, OR 97224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMC-950 C-ARM MOBILE SYSTEM
UNITED RADIOLOGY SYSTEMS, INC. 510(k) NO: K032761(TRADITIONAL)
ATTN: JOHN W LEE PHONE NO : 847-291-0999
151 SOUTH PFINGSTEN RD. SE DECISION MADE: 14-MAY-04
UNIT T 510(k) SUMMARY AVAILABLE FROM FDA
DEERFIELD, IL 60015
DEVICE: GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH
VASCUTEK LTD. 510(k) NO: K040829(TRADITIONAL)
ATTN: STEVEN ARICK PHONE NO : 734-741-6238
6200 JACKSON RD. SE DECISION MADE: 20-MAY-04
ANN ARBOR, MI 48103-9300 510(k) STATEMENT
DEVICE: LAFACI
VISION PRO, L.L.C. 510(k) NO: K032400(TRADITIONAL)
ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340
1050 CONNECTICUT AVENUE, NW SE DECISION MADE: 07-MAY-04
WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
VITEL NET 510(k) NO: K040581(TRADITIONAL)
ATTN: ALLEN IZADPANAH PHONE NO : 703-448-0999
8201 GREENSBORO DR. SE DECISION MADE: 27-MAY-04
SUITE 820 510(k) SUMMARY AVAILABLE FROM FDA
MCLEAN, VA 22102
DEVICE: G-FREEZEKIT BLAST
VITROLIFE AB 510(k) NO: K032154(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVE. NW SE DECISION MADE: 07-MAY-04
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-THAWKIT BLAST
VITROLIFE AB 510(k) NO: K032155(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVE. NW SE DECISION MADE: 07-MAY-04
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-OOCYTE
VITROLIFE SWEDEN AB 510(k) NO: K032877(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 07-MAY-04
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-PGD
VITROLIFE SWEDEN AB 510(k) NO: K033101(TRADITIONAL)
ATTN: GARY L YINGLING PHONE NO : 202-778-9124
1800 MASSACHUSETTS AVENUE NW SE DECISION MADE: 07-MAY-04
WASHINGTON, DC 20036-1800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATH
VYGON US LLC 510(k) NO: K033704(SPECIAL)
ATTN: COURTNEY SMITH PHONE NO : 610-539-9300
2495 GENERAL ARMSTEAD AVE. SE DECISION MADE: 27-MAY-04
NORRISTOWN, PA 19403 510(k) STATEMENT
DEVICE: GORE TRI-LOBE BALLOON CATHETER
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K033670(TRADITIONAL)
ATTN: BRANDON HANSEN PHONE NO : 928-864-3784
3450 WEST KILTIE LN. SE DECISION MADE: 05-MAY-04
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRST SIGN DRUG OF ABUSE SCREENING TEST
W.H.P.M., INC. 510(k) NO: K032575(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 19-MAY-04
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE-STEP PREGNANCY TEST
W.H.P.M., INC. 510(k) NO: K041273(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 20-MAY-04
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
WAKO CHEMICALS, USA, INC. 510(k) NO: K040918(TRADITIONAL)
ATTN: LORI CREASY PHONE NO : 877-714-1924
1600 BELLWOOD RD. SE DECISION MADE: 17-MAY-04
RICHMOND, VA 23237 510(k) STATEMENT
DEVICE: LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
WALTER LORENZ SURGICAL, INC. 510(k) NO: K030425(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-9443
1520 TRADEPORT DR. SE DECISION MADE: 14-MAY-04
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ SELF-DRILLING IMF SCREW
WALTER LORENZ SURGICAL, INC. 510(k) NO: K040983(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-9443
1520 TRADEPORT DR. SE DECISION MADE: 05-MAY-04
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
WALTER LORENZ SURGICAL, INC. 510(k) NO: K040990(SPECIAL)
ATTN: KIM REED PHONE NO : 904-741-9443
1520 TRADEPORT DR. SE DECISION MADE: 13-MAY-04
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYDON C
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K040384(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 14-MAY-04
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINON
WAVELIGHT LASER TECHNOLOGIE AG 510(k) NO: K040433(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 19-MAY-04
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&I; SCOOTER, SC-301
WELL SUCCESS BIOTECH INC. 510(k) NO: K041187(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&I; POWER WHEELCHAIR, PC-401
WELL SUCCESS BIOTECH INC. 510(k) NO: K041190(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A&I; SCOOTER, SC-402
WELL SUCCESS BIOTECH INC. 510(k) NO: K041193(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-MAY-04
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, W
WELL-LIFE HEALTHCARE, INC. 510(k) NO: K040512(TRADITIONAL)
ATTN: MIKE PRICE PHONE NO : 615-865-4000
1109 MYATT BLVD. SE DECISION MADE: 27-MAY-04
MADISON, TN 37115 510(k) STATEMENT
DEVICE: PORTA SOLDER 1090 W
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K040524(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 137050
SCHWENNINGER STRABE 13 SE DECISION MADE: 20-MAY-04
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTA REFLEX
WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K040672(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 49 723 137050
SCHWENNINGER STRABE 13 SE DECISION MADE: 27-MAY-04
PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
WILSON-COOK MEDICAL, INC. 510(k) NO: K040324(TRADITIONAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. SE DECISION MADE: 20-MAY-04
WINSTON-SALEM, NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USW NEEDLEKNIFE PAPILLOTOME
WILSON-COOK MEDICAL, INC. 510(k) NO: K040981(SPECIAL)
ATTN: MARGE WALLS-WALKER PHONE NO : 336-744-0157
4900 BETHANIA STATION RD. & SE DECISION MADE: 07-MAY-04
5951 GRASSY CREEK BLVD. 510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27105
DEVICE: PROFEMUR TAPERED HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K041114(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 28-MAY-04
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALP
WRP SPECIALTY PRODUCTS SDN. BHD. 510(k) NO: K032016(TRADITIONAL)
ATTN: V. NADARAJAN PHONE NO : 60 387 069788
LOT 11, JALAN 2, KAWASAN SE DECISION MADE: 11-MAY-04
PERUSAHAAN BANDAR BARU SALAK 510(k) SUMMARY AVAILABLE FROM FDA
TINGGI, SEPANG, SELANGOR, MALAYSIA 43900
DEVICE: ZARGIS ACOUSTIC CARDIOSCAN
ZARGIS MEDICAL CORP. 510(k) NO: K031517(TRADITIONAL)
ATTN: SHAHRAM HEJAZI PHONE NO : 609-734-6530
755 COLLEGE RD. EAST SE DECISION MADE: 26-MAY-04
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COONRAD/MORREY ELBOW CEMENT RESTRICTOR
ZIMMER, INC. 510(k) NO: K040389(TRADITIONAL)
ATTN: NOAH J BARTSCH PHONE NO : 574-371-8552
P.O. BOX 708 SE DECISION MADE: 17-MAY-04
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL AED PLUS
ZOLL MEDICAL CORP. 510(k) NO: K033474(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 800-242-9150
269 MILL ROAD SE DECISION MADE: 21-MAY-04
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 289
TOTAL WITH SUMMARIES 246
TOTAL WITH STATEMENTS 43
Updated June 7, 2004
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