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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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