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510(k)s Final Decisions Rendered for May 2003 |
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-MAY-2003 THROUGH 31-MAY-2003 DEVICE: L600 HAIR REMOVAL A&M TECHNOLOGY 510(k) NO: K030480(TRADITIONAL) ATTN: PASCAL DANET PHONE NO : 003 315 6891040 28, RUE DE LA TREMOILLE SE DECISION MADE: 14-MAY-03 PARIS, FRANCE F 75008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CELL-DYN 1800 SYSTEM ABBOT LABORATORIES 510(k) NO: K030513(TRADITIONAL) ATTN: JOHN DEAN PHONE NO : 408-567-3430 5440 PATRICK HENRY DR. SE DECISION MADE: 12-MAY-03 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APTUS BLUE ACADENTAL 510(k) NO: K030884(ABBREVIATED) ATTN: CHRISTOPHER CRAIG PHONE NO : 913-384-7390 5830 WOODSON ST. SE DECISION MADE: 27-MAY-03 SUITE 5 510(k) SUMMARY AVAILABLE FROM FDA MISSION, KS 66202 DEVICE: ACMI VISTA CTR BIPOLAR LOOP ELECTRODE ACMI CORPORATION 510(k) NO: K031001(SPECIAL) ATTN: GABRIEL J MURACA PHONE NO : 508-804-2754 136 TURNPIKE RD. SE DECISION MADE: 21-MAY-03 SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS 510(k) NO: K031226(SPECIAL) ATTN: NATALIE BENNINGTON PHONE NO : 949-453-6410 33 TECHNOLOGY DR. SE DECISION MADE: 02-MAY-03 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) AESCULAP 510(k) NO: K031008(TRADITIONAL) ATTN: MATTHEW M HULL PHONE NO : 800-258-1946 3773 CORPORATE PKWY. SE DECISION MADE: 09-MAY-03 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE AESCULAP, INC. 510(k) NO: K031286(SPECIAL) ATTN: GEORG KELLER PHONE NO : 610-797-9300 3773 CORPORATE PKWY. SE DECISION MADE: 29-MAY-03 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIRLIFE DEMAND NASAL CANNULA ALLEGIANCE HEALTHCARE CORP. 510(k) NO: K023673(TRADITIONAL) ATTN: SHARON NICHOLS PHONE NO : 847-785-3311 1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 02-MAY-03 MCGAW PARK, IL 60085 510(k) STATEMENT DEVICE: SMALL VOLUME NEBULIZER ALLEGIANCE HEALTHCARE CORPORATION 510(k) NO: K023602(SPECIAL) ATTN: SHARON NICHOLS PHONE NO : 847-785-3311 1500 WAUKEGAN RD., BLDG. WM SE DECISION MADE: 01-MAY-03 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. 510(k) NO: K030026(TRADITIONAL) ATTN: MOIRA BARTON PHONE NO : 480-763-5300 10232 SOUTH 51ST ST. SE DECISION MADE: 02-MAY-03 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. 510(k) NO: K030947(TRADITIONAL) ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510 401 NORTH TRYON ST. SE DECISION MADE: 15-MAY-03 10TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28202 DEVICE: 'RAPID ONE' - PROPOXYPHENE TEST AMERICAN BIO MEDICA CORP. 510(k) NO: K030835(TRADITIONAL) ATTN: HENRY WELLS PHONE NO : 410-992-4734 9110 RED BRANCH RD. SE DECISION MADE: 22-MAY-03 COLUMBIA, MD 21945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMERITEK SURE-POINT TRACKER SYSTEM AMERTEK MEDICAL, INC. 510(k) NO: K030518(TRADITIONAL) ATTN: GREG WIITA PHONE NO : 561-842-7595 2655 NORTH OCEAN DR. SE DECISION MADE: 20-MAY-03 SINGER ISLAND, FL 33404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSURE FOLEY INSERTION TRAY AMSINO INTERNATIONAL, INC. 510(k) NO: K030664(TRADITIONAL) ATTN: CHING CHING SEAH PHONE NO : 909-390-5688 4501 BRICKELL PRIVADO ST. SE DECISION MADE: 23-MAY-03 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: AMSURE URETHRAL CATHETERIZATION TRAY AMSINO INTERNATIONAL, INC. 510(k) NO: K030712(TRADITIONAL) ATTN: CHING CHING SEAH PHONE NO : 909-390-5688 4501 BRICKELL PRIVADO ST. SE DECISION MADE: 23-MAY-03 ONTARIO, CA 91761 510(k) STATEMENT DEVICE: C3 PATIENT MONITOR ANALOGIC CORP. 510(k) NO: K030931(SPECIAL) ATTN: MARVIN ROSENBAUM PHONE NO : 978-977-3000 8 CENTENNIAL DR. SE DECISION MADE: 09-MAY-03 PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX MODULAR ACETABULAR CUP APEX SURGICAL, LLC. 510(k) NO: K031110(TRADITIONAL) ATTN: EDWARD J CHEAL PHONE NO : 508-947-6500 12 HARDING STREET,SUITE 202 SE DECISION MADE: 22-MAY-03 LAKEVILLE, MA 02347 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFLECTING URETERAL ACCESS SHEATH APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K030642(TRADITIONAL) ATTN: ANIL BHALANI PHONE NO : 949-713-8327 22872 AVENIDA EMPRESSA SE DECISION MADE: 23-MAY-03 RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIATEK CANNON-CATHETER, MODEL CC5500 ARROW INTL., INC. 510(k) NO: K022662(TRADITIONAL) ATTN: THOMAS NICKEL PHONE NO : 610-478-3137 2400 BERNVILLE RD. SE DECISION MADE: 09-MAY-03 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA BF1 (VITALIO) BODY FAT ANALYZER AVITA CORPORATION 510(k) NO: K020738(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL, SE DECISION MADE: 22-MAY-03 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) AVITA CORPORATION 510(k) NO: K030230(TRADITIONAL) ATTN: JENNIFER REICH PHONE NO : 928-773-9488 3892 SOUTH AMERICA WEST TRAIL, SE DECISION MADE: 23-MAY-03 FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEDIATRIC CENTRAL VENOUS CATHETER KIT B. BRAUN MEDICAL, INC. 510(k) NO: K023253(TRADITIONAL) ATTN: PATRICIA D WILSON PHONE NO : 610-266-0500 901 MARCON BLVD. SE DECISION MADE: 06-MAY-03 ALLENTOWN, PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION BAUSCH & LOMB INCORPORATED 510(k) NO: K024289(TRADITIONAL) ATTN: JENNIFER B MURRAY PHONE NO : 585-338-8460 1400 N GOODMAN ST. SE DECISION MADE: 02-MAY-03 ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 3 BD VACUTAINER SYSTEMS PREANALYICAL510(k) NO: K030573(TRADITIONAL) ATTN: M. WENDY BALLESTEROS PHONE NO : 201-847-6280 1 BECTON DR., BECTON BLDG. SE DECISION MADE: 08-MAY-03 FRANKLIN LAKES, NJ 07417-1885 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) BECKMAN COULTER, INC. 510(k) NO: K030828(ABBREVIATED) ATTN: STAN SUGRUE PHONE NO : 305-380-4552 11800 SW 147TH AVE. SE DECISION MADE: 21-MAY-03 MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. 510(k) NO: K031269(SPECIAL) ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 02-MAY-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. 510(k) NO: K031270(SPECIAL) ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 06-MAY-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESS OV MONITOR ASSAY BECKMAN COULTER, INC. 510(k) NO: K031297(SPECIAL) ATTN: LYNN WEIST PHONE NO : 952-368-1271 1000 LAKE HAZELTINE DR. SE DECISION MADE: 02-MAY-03 CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-1 BECTON, DICKINSON AND COMPANY 510(k) NO: K030986(TRADITIONAL) ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287 7 LOVETON CIR. SE DECISION MADE: 16-MAY-03 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STACKED ABR FOR NAVIGATOR PRO BIO-LOGIC SYSTEMS CORP. 510(k) NO: K030907(SPECIAL) ATTN: NORMAN E BRUNNER PHONE NO : 847-949-5200 ONE BIO-LOGIC PLAZA SE DECISION MADE: 09-MAY-03 MUNDELEIN, IL 60060-3700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 BIO-RAD 510(k) NO: K023857(TRADITIONAL) ATTN: CHRISTOPHER BENTSEN PHONE NO : 425-881-8300 CLINICAL DIAGNOSTICS GROUP SE DECISION MADE: 16-MAY-03 6565 185TH AVENUE NE 510(k) SUMMARY AVAILABLE FROM FDA REDMOND, WA 98052 DEVICE: BIOMET CRANIOFACIAL ACRYLIC CEMENT BIOMET, INC. 510(k) NO: K011399(TRADITIONAL) ATTN: MICHELLE L MCKINLEY PHONE NO : 219-267-6639 AIRPORT INDUSTRIAL PARK SE DECISION MADE: 05-MAY-03 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: TEXAS T - PLATE BIOMET, INC. 510(k) NO: K031334(TRADITIONAL) ATTN: GARY BAKER PHONE NO : 574-267-6639 56 BELL DR. SE DECISION MADE: 22-MAY-03 PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: INBODY AP1 BODY COMPOSITION ANALYZER BIOSPACE CO.,LTD 510(k) NO: K023478(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847-374-1727 PO BOX 7007 SE DECISION MADE: 13-MAY-03 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY CLOCK TENS N' TONE BODY CLOCK HEALTH CARE LTD 510(k) NO: K022849(TRADITIONAL) ATTN: JONATHAN BASH PHONE NO : 44 20 85329551 108 GEORGE LANE SE DECISION MADE: 20-MAY-03 LONDON, ENGLAND, UNITED KINGDOM E1510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM BONSO ELECTRONICS INTERNATIONAL IN510(k) NO: K030349(TRADITIONAL) ATTN: RUSS PAGANO PHONE NO : 202-546-1262 719 A STREET, NE SE DECISION MADE: 02-MAY-03 WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVIGATOR URETERAL ACCESS SHEATH SET BOSTON SCIENTIFIC CORP. 510(k) NO: K030956(SPECIAL) ATTN: JANET A MCGRATH PHONE NO : 508-650-8726 ONE BOSTON SCIENTIFIC PLACE SE DECISION MADE: 23-MAY-03 NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE BOSTON SCIENTIFIC SCIMED, INC. 510(k) NO: K030617(ABBREVIATED) ATTN: ANNE V ROSSI PHONE NO : 763-494-2323 ONE SCIMED PLACE SE DECISION MADE: 21-MAY-03 MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATRIX STRETCH RESISTANT DETACHABLE COIL BOSTON SCIENTIFIC, TARGET 510(k) NO: K031168(SPECIAL) ATTN: JAMES LEATHLEY PHONE NO : 510-440-7836 47900 BAYSIDE PKWY. SE DECISION MADE: 14-MAY-03 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDIPALM-20 BRAEBON MEDICAL CORP. 510(k) NO: K031202(TRADITIONAL) ATTN: RICHARD A BONATO PHONE NO : 888 462 4841 120 WALGREEN DR. SE DECISION MADE: 01-MAY-03 SUITE #1, RR#3 510(k) SUMMARY AVAILABLE FROM FDA CARP, ONTARIO, CANADA KOA 1LO THIRD PARTY REVIEW DEVICE: BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. 510(k) NO: K030489(TRADITIONAL) ATTN: CHRIS MANDER PHONE NO : 011 649 9788896 25 CARBINE ROAD MT. WELLINGTON SE DECISION MADE: 02-MAY-03 PO BOX 51-078, PARURANGA 510(k) SUMMARY AVAILABLE FROM FDA AUCKLAND, NEW ZEALAND THIRD PARTY REVIEW DEVICE: CO2 CLIP BREGAS AB 510(k) NO: K023820(TRADITIONAL) ATTN: PAUL KRILL PHONE NO : 468 629 2754 ULVSUNDAVAGEN 178B SE DECISION MADE: 07-MAY-03 BROMMA, SWEDEN SE-16867 510(k) STATEMENT DEVICE: POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC C.R. BARD, INC. 510(k) NO: K031129(SPECIAL) ATTN: PEGGY KEIFFER PHONE NO : 801-595-0700 5425 WEST AMELIA EARHART DR. SE DECISION MADE: 05-MAY-03 SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMINEXX ENDOSCOPIC BILIARY STENT C.R. BARD, INC. 510(k) NO: K031186(SPECIAL) ATTN: THOMAS HIRTE PHONE NO : 978-262-4867 129 CONCORD RD. SE DECISION MADE: 06-MAY-03 BUILDING 3 510(k) SUMMARY AVAILABLE FROM FDA BILLERICA, MA 01821 DEVICE: BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM C.R. BARD, INC. 510(k) NO: K031295(TRADITIONAL) ATTN: FRANCES E HARRISON PHONE NO : 770-784-6257 8195 INDUSTRIAL BLVD. SE DECISION MADE: 15-MAY-03 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH C.R. BARD, INC. 510(k) NO: K031332(ABBREVIATED) ATTN: TERRINA WILDER PHONE NO : 770-784-6160 8195 INDUSTRIAL BLVD. SE DECISION MADE: 15-MAY-03 COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-120 C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K031272(TRADITIONAL) ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651 3636 E. COLUMBINE DR. SE DECISION MADE: 20-MAY-03 PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G CANON INC. 510(k) NO: K031447(TRADITIONAL) ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 21-MAY-03 LAKE SUCCESS, NY 11042 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 CARDIAC ASSIST, INC. 510(k) NO: K030398(TRADITIONAL) ATTN: TIM KRAUSKOPF PHONE NO : 412-963-7770 240 ALPHA DR. SE DECISION MADE: 23-MAY-03 PITTSBURGH, PA 15238 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRATUSOCT WITH RNFL NORMATIVE DATABASE CARL ZEISS MEDITEC INC 510(k) NO: K030433(TRADITIONAL) ATTN: R. MICHAEL CROMPTON PHONE NO : 925-557-4353 5160 HACIENDA DR. SE DECISION MADE: 01-MAY-03 DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REBILDA DC CASCADES DEVICE CONSULTING ASSOCIA510(k) NO: K030914(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 30-MAY-03 BEND, OR 97702-1923 510(k) STATEMENT DEVICE: GRANDIO CASCADES DEVICE CONSULTING ASSOCIA510(k) NO: K030915(TRADITIONAL) ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935 19379 BLUE LAKE LOOP SE DECISION MADE: 30-MAY-03 BEND, OR 97702-1923 510(k) STATEMENT DEVICE: STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRO CASE MEDICAL, INC. 510(k) NO: K022978(TRADITIONAL) ATTN: MARCIA A FRIEZE PHONE NO : 201-313-1999 65 RAILROAD AVE. SE DECISION MADE: 09-MAY-03 RIDGEFIELD, NJ 07657-0402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBIL CLEARLAB PTE LTD. 510(k) NO: K030748(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DR. SE DECISION MADE: 14-MAY-03 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN ISOCOOL BIPOLAR FORCEPS CODMAN & SHURTLEFF, INC. 510(k) NO: K023566(TRADITIONAL) ATTN: ELIZABETH DOLAN PHONE NO : 508-828-3262 325 PARAMOUNT DR. SE DECISION MADE: 22-MAY-03 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN BACTISEAL BARIUM STRIPED CATHETERS CODMAN & SHURTLEFF, INC. 510(k) NO: K031123(SPECIAL) ATTN: ELIZABETH DOLAN PHONE NO : 508-828-3262 325 PARAMOUNT DR. SE DECISION MADE: 14-MAY-03 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLAGEN TOPICAL WOUND DRESSING COLLAGEN MATRIX, INC. 510(k) NO: K030921(TRADITIONAL) ATTN: PEGGY HANSEN PHONE NO : 201-405-1477 509 COMMERCE ST. SE DECISION MADE: 15-MAY-03 FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 COLLINS MEDICAL, INC. 510(k) NO: K030917(SPECIAL) ATTN: DONALD HENTON PHONE NO : 781-843-0610 220 WOOD RD. SE DECISION MADE: 14-MAY-03 BRAINTREE, MA 02184-2403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHUMP COLOURS 'N MOTION 510(k) NO: K030017(TRADITIONAL) ATTN: VICTOR R BOX PHONE NO : 714-978-1440 1591 SOUTH SINCLAIR ST. SE DECISION MADE: 01-MAY-03 ANAHEIM, CA 92806 510(k) STATEMENT DEVICE: COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K030355(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO.58,FU-CHIUN ST. SE DECISION MADE: 20-MAY-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 COMFORT ORTHOPEDIC CO. LTD. 510(k) NO: K030356(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO 58 FU-CHIUN ST. SE DECISION MADE: 20-MAY-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: ETCHANT 40% CONFI-DENTAL PRODUCTS CO. 510(k) NO: K030743(TRADITIONAL) ATTN: STEPHEN RUDOLPH PHONE NO : 303-665-7535 416 SOUTH TAYLOR AVE. SE DECISION MADE: 09-MAY-03 LOUISVILLE, CO 80027-3028 510(k) STATEMENT DEVICE: SURGISIS NERVE CUFF COOK BIOTECH, INC. 510(k) NO: K031069(TRADITIONAL) ATTN: MARK BLEYER PHONE NO : 765-497-3355 3055 KENT AVE. SE DECISION MADE: 15-MAY-03 WEST LAFAYETTE, IN 47906-1076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM COOK VASCULAR, INC. 510(k) NO: K023937(TRADITIONAL) ATTN: THOMAS J KARDOS PHONE NO : 724-845-8621 RT. 66, RIVER RD. SE DECISION MADE: 27-MAY-03 P.O. BOX 529 510(k) SUMMARY AVAILABLE FROM FDA LEECHBURG, PA 15656 DEVICE: SPECTRUM SILICONE CATHETER COOK, INC. 510(k) NO: K021557(TRADITIONAL) ATTN: APRIL LAVENDER PHONE NO : 812-339-2235 925 SOUTH CURRY PIKE SE DECISION MADE: 30-MAY-03 P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA BLOOMINGTON, IN 47402 DEVICE: COZART EIA COTININE URINE KIT COZART BIOSCIENCE LTD. 510(k) NO: K021944(TRADITIONAL) ATTN: ROBERTO LIDDI PHONE NO : 012 358 61483 45 MILTON PARK SE DECISION MADE: 14-MAY-03 ABINGDON 510(k) SUMMARY AVAILABLE FROM FDA OXFORDSHIRE OX14 4RU, UNITED KINGDOM OX14 4RU DEVICE: MONO-SWIFT CP MEDICAL 510(k) NO: K030786(ABBREVIATED) ATTN: MARY ANN GREENAWALT PHONE NO : 503-232-1555 836 N.E. 24TH AVE. SE DECISION MADE: 06-MAY-03 PORTLAND, OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART CO2 (SMART US 20D, SMART CLINIC) LASER CYNOSURE, INC. 510(k) NO: K031224(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 09-MAY-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART 2940 D ER: YAG LASER CYNOSURE, INC. 510(k) NO: K031317(SPECIAL) ATTN: GEORGE CHO PHONE NO : 978-256-4200 10 ELIZABETH DR. SE DECISION MADE: 22-MAY-03 CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TPSA FLEX REAGENT CARTRIDGE DADE BEHRING, INC. 510(k) NO: K031343(SPECIAL) ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798 BLDG. 500 MAIL BOX 514 SE DECISION MADE: 15-MAY-03 P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714-6101 DEVICE: DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOF DATEX-OHMEDA 510(k) NO: K030812(TRADITIONAL) ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIM RD. SE DECISION MADE: 21-MAY-03 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP DELTEC, INC. 510(k) NO: K031361(SPECIAL) ATTN: LISA STONE PHONE NO : 651-628-7224 1265 GREY FOX RD. SE DECISION MADE: 23-MAY-03 ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGI-SYSTEM DENX ADVANCED DENTAL SYSTEMS LTD. 510(k) NO: K023424(TRADITIONAL) ATTN: KOBY BEN-BARAK PHONE NO : 972 499 40337 MIZPE AVIV, INDUSTRIAL PARK 13 SE DECISION MADE: 09-MAY-03 M.P. MISGAV, ISRAEL 20187 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPILASE YAG LASE PLUS LASER SYSTEM DEPILASE GROUP LTD. 510(k) NO: K030506(TRADITIONAL) ATTN: MARIO LUCA RUSSO PHONE NO : 442 077 121675 ONE CANADA SQUARE SE DECISION MADE: 09-MAY-03 CANARY WHARF 510(k) SUMMARY AVAILABLE FROM FDA LONDON, UNITED KINGDOM E14 5DY DEVICE: DEPILASE TRIO LASE LASER SYSTEM DEPILASE GROUP LTD. 510(k) NO: K030508(TRADITIONAL) ATTN: MARIO LUCA RUSSO PHONE NO : 442 077 121675 ONE CANADA SQUARE SE DECISION MADE: 20-MAY-03 CANARY WHARF 510(k) SUMMARY AVAILABLE FROM FDA LONDON, UNITED KINGDOM E14 5DY DEVICE: DEPILASE TWIN YAG LASER SYSTEM DEPILASE GROUP LTD. 510(k) NO: K030510(TRADITIONAL) ATTN: MARIO LUCA RUSSO PHONE NO : 442 077 121675 ONE CANADA SQUARE SE DECISION MADE: 14-MAY-03 CANARY WHARF 510(k) SUMMARY AVAILABLE FROM FDA LONDON, UNITED KINGDOM E14 5DY DEVICE: SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR DIDECO S.P.A. 510(k) NO: K031223(SPECIAL) ATTN: BARRY SALL PHONE NO : 781-434-4742 195 WEST ST. SE DECISION MADE: 02-MAY-03 WALTHAM, MA 02451-1163 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) DISC-O-TECH MEDICAL TECHNOLOGIES, 510(k) NO: K030972(SPECIAL) ATTN: HILA WACHSLER-AVRAHAMI PHONE NO : 972 9 9511511 3 HASADNAOT SE DECISION MADE: 30-MAY-03 HERZELIA, ISRAEL 46728 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL DISCUS DENTAL, INC. 510(k) NO: K030776(TRADITIONAL) ATTN: YOGI SHAH PHONE NO : 310-845-8511 8550 HIGUERA ST. SE DECISION MADE: 09-MAY-03 CULVER CITY, CA 90232 510(k) STATEMENT DEVICE: DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 231 DOLPHIN MEDICAL INC. 510(k) NO: K030952(SPECIAL) ATTN: BILL CURNAN PHONE NO : 720-348-0389 9433 S. MORNING GLORY LN. SE DECISION MADE: 19-MAY-03 HIGHLANDS RANCH, CO 80130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW EASTMAN KODAK COMPANY 510(k) NO: K030781(TRADITIONAL) ATTN: LINDA J MOORE PHONE NO : 510-770-5456 47315 MISSION FALLS CT SE DECISION MADE: 29-MAY-03 FREMONT, CA 94539 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 20.1" MONOCHROME LCD MONITOR, RADIFORCE G20 EIZO NANAO CORPORATION 510(k) NO: K030347(TRADITIONAL) ATTN: AKIRA WAKAYAMA PHONE NO : 81 596 370190 319 AKENO, OBATA-CHO SE DECISION MADE: 02-MAY-03 WATARAI-GUN, MIE-KEN, JAPAN 519-05510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE POWDERED VINYL EXAM GLOVES ELITE INTERNATIONAL, INC. 510(k) NO: K031134(TRADITIONAL) ATTN: BOBBY LING PHONE NO : 800-788-9486 18709 GREENBAY DR. SE DECISION MADE: 20-MAY-03 ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT DEVICE: ENCORE ANTERIOR SPINAL STAPLE SYSTEM ENCORE MEDICAL, L.P. 510(k) NO: K030667(TRADITIONAL) ATTN: DEBBIE DE LOS SANTOS PHONE NO : 512-832-9500 9800 METRIC BLVD. SE DECISION MADE: 28-MAY-03 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MOD ETHICON ENDO-SURGERY, INC. 510(k) NO: K030925(TRADITIONAL) ATTN: CAROL SPRINKLE PHONE NO : 513-337-3792 4545 CREEK RD. SE DECISION MADE: 15-MAY-03 CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEMEX SYSTEM FAST EXACTECH, INC. 510(k) NO: K031430(SPECIAL) ATTN: GARY J MILLER PHONE NO : 352-377-1140 2320 N.W. 66TH CT. SE DECISION MADE: 22-MAY-03 GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYREX PRE-FILLED SYRINGE EXCELSIOR MEDICAL CORP. 510(k) NO: K023740(TRADITIONAL) ATTN: DAVID LUMIA PHONE NO : 732-776-7525 1923 HECK AVE. SE DECISION MADE: 13-MAY-03 NEPTUNE, NJ 07753 510(k) STATEMENT DEVICE: TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER FMD, LLC 510(k) NO: K030346(TRADITIONAL) ATTN: STEVEN CHERNOFF PHONE NO : 425-861-8262 P.O. BOX 3515 SE DECISION MADE: 02-MAY-03 REDMOND, WA 98073-3515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONI FMS, FINAPRES MEDICAL SYSTEMS BV 510(k) NO: K023338(TRADITIONAL) ATTN: CHRISTINE EMANUEL PHONE NO : 805-963-4312 1205 DE LA VINA ST. SE DECISION MADE: 09-MAY-03 SANTA BARBARA, CA 93101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO FOSSA URETERAL STONE SWEEPER FOSSA MEDICAL, INC. 510(k) NO: K031292(SPECIAL) ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVE. SE DECISION MADE: 22-MAY-03 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, FRESENIUS MEDICAL CARE 510(k) NO: K030497(TRADITIONAL) ATTN: ART EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 20-MAY-03 LEXINGTON, MA 02420 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRESENIUS ULTRAFLUX HEMODIALYZER FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K031378(SPECIAL) ATTN: ARTHUR EILINSFELD PHONE NO : 781-402-9068 95 HAYDEN AVE. SE DECISION MADE: 30-MAY-03 LEXINGTON, MA 02420-9192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADHOC CLAW FUTURE MEDICAL SYSTEMS, INC. 510(k) NO: K023963(TRADITIONAL) ATTN: STEVE JANIN PHONE NO : 410-761-9411 504 MCCORMICK DR., SUITE T SE DECISION MADE: 05-MAY-03 GLEN BURNIE, MD 21061 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM GALIL MEDICAL LTD. 510(k) NO: K031117(SPECIAL) ATTN: RONI ZVULONI PHONE NO : 972 495 91080 YOKNEAM GATE, 1 TAVOR BLDG. SE DECISION MADE: 23-MAY-03 YOKNEAM, ISRAEL 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO POLYFLUX, MODEL 140H, 170H, 210H GAMBRO RENAL CARE PRODUCTS 510(k) NO: K030592(TRADITIONAL) ATTN: JEFFREY R SCHIDMAN PHONE NO : 952-835-4018 10810 W. COLLINS AVE. SE DECISION MADE: 23-MAY-03 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR GAMBRO RENAL PRODUCTS 510(k) NO: K023615(TRADITIONAL) ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018 10810 W. COLLINS AVE. SE DECISION MADE: 06-MAY-03 LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE PROPELLER IMAGING OPTION FOR MRI GE MEDICAL SYSTEMS 510(k) NO: K031230(TRADITIONAL) ATTN: LARRY KROGER PHONE NO : 262-544-3894 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 02-MAY-03 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARD EP GE MEDICAL SYSTEMS 510(k) NO: K031261(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. 414 SE DECISION MADE: 06-MAY-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADVANTAGE WORKSTATION PASTING 1.1 GE MEDICAL SYSTEMS 510(k) NO: K031396(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 3000 N GRANDVIEW BLVD. SE DECISION MADE: 13-MAY-03 W-400 510(k) SUMMARY AVAILABLE FROM FDA WAUKESHA, WI 53188 THIRD PARTY REVIEW DEVICE: DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K022834(TRADITIONAL) ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133 4502 WOODLAND CORP.BLVD. SE DECISION MADE: 13-MAY-03 TAMPA, FL 33614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EK-PRO ARRHYTHMIA DETECTION ALGORITHM GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K031320(SPECIAL) ATTN: KAREN M LUNDE PHONE NO : 414-362-3329 8200 WEST TOWER AVE. SE DECISION MADE: 06-MAY-03 MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CT COLONOGRAPHY GE MEDICAL SYSTEMS, INC. 510(k) NO: K023943(TRADITIONAL) ATTN: LARRY A KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 06-MAY-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE 1.5T 8 CHANNEL TORSO COIL GE MEDICAL SYSTEMS, INC. 510(k) NO: K031209(SPECIAL) ATTN: LARRY KROGER PHONE NO : 262-544-3894 P.O. BOX 414 SE DECISION MADE: 23-MAY-03 MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER GETINGE USA, INC 510(k) NO: K031259(SPECIAL) ATTN: FREDERICK R CATT PHONE NO : 800-475-9040 1777 EAST HENRIETTA RD. SE DECISION MADE: 12-MAY-03 ROCHESTER, NY 14623-3133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING GISH BIOMEDICAL, INC. 510(k) NO: K030726(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 30-MAY-03 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBC FLOPUMP WITH GBS COATING GISH BIOMEDICAL, INC. 510(k) NO: K031300(TRADITIONAL) ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 14-MAY-03 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM GUIDANT CORP. 510(k) NO: K030512(TRADITIONAL) ATTN: NANCY LINCE PHONE NO : 408-845-1842 3200 LAKESIDE DR. SE DECISION MADE: 14-MAY-03 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IS-1 HEMOSTASIS VALVE, MODEL 6799 GUIDANT CORP. 510(k) NO: K031398(SPECIAL) ATTN: COLLEEN MCCARTER BLOOM PHONE NO : 651-582-4000 4100 HAMLINE AVE., NORTH SE DECISION MADE: 20-MAY-03 ST. PAUL, MN 55112-5798 510(k) STATEMENT DEVICE: HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDCORP 510(k) NO: K030549(SPECIAL) ATTN: STACEY BROWN PHONE NO : 909-914-4527 26531 YNEZ RD. SE DECISION MADE: 14-MAY-03 TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADA GYRUS ENT L.L.C. 510(k) NO: K030343(TRADITIONAL) ATTN: GREGORY SREDIN PHONE NO : 901-373-0200 2925 APPLING RD. SE DECISION MADE: 02-MAY-03 BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MAC GYRUS MEDICAL, INC. 510(k) NO: K031078(SPECIAL) ATTN: MERCEDES P BAYANI PHONE NO : 763-416-3000 6655 WEDGWOOD RD. SE DECISION MADE: 16-MAY-03 MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTROD GYRUS MEDICAL, INC. 510(k) NO: K031079(SPECIAL) ATTN: MERCEDES BAYANI PHONE NO : 763-416-3000 6655 WEDGWOOD RD. SE DECISION MADE: 21-MAY-03 MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS D GYRUS MEDICAL, INC. 510(k) NO: K031080(SPECIAL) ATTN: MERCEDES BIRYANI PHONE NO : 763-416-3000 6655 WEDGWOOD RD. SE DECISION MADE: 16-MAY-03 MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS GYRUS MEDICAL, INC. 510(k) NO: K031081(SPECIAL) ATTN: MERCEDES BAYANI PHONE NO : 763-416-3000 6655 WEDGWOOD RD. SE DECISION MADE: 21-MAY-03 MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK GYRUS MEDICAL, INC. 510(k) NO: K031082(SPECIAL) ATTN: MERCEDES P BAYANI PHONE NO : 763-416-3000 6655 WEDGWOOD RD. SE DECISION MADE: 21-MAY-03 MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS HANS RUDOLPH, INC. 510(k) NO: K030515(TRADITIONAL) ATTN: KEVIN RUDOLPH PHONE NO : 816-363-5522 7200 WYANDOTTE SE DECISION MADE: 02-MAY-03 KANSAS CITY, MO 64114 510(k) STATEMENT DEVICE: POWDERED VINYL EXAM GLOVES, WHITE HEYUAN HONGLI INDUSTRIES, INC. 510(k) NO: K030997(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775-342-2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 02-MAY-03 SPARKS, NV 89434-9550 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIVOX DREAMATE DM-800 HIVOX BIOTEK, INC. 510(k) NO: K021952(TRADITIONAL) ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 02-MAY-03 HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT DEVICE: HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HOME CARE TECHNOLOGY CO., LTD. 510(k) NO: K022998(TRADITIONAL) ATTN: SHU-CHEN CHENG PHONE NO : 614-451-1918 2064 TAMARIN DR. SE DECISION MADE: 20-MAY-03 COLUMBUS, OH 43235 510(k) STATEMENT DEVICE: GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS 510(k) NO: K031217(TRADITIONAL) ATTN: MARGARET F CROWE PHONE NO : 201-831-5580 59 ROUTE 17 SE DECISION MADE: 23-MAY-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGICAL SIMPLEX P WITH TOBRAMYCIN HOWMEDICA OSTEONICS CORP. 510(k) NO: K014199(TRADITIONAL) ATTN: WILLIAM J CYMBALUK PHONE NO : 201-825-4900 59 ROUTE 17 SE DECISION MADE: 06-MAY-03 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER HWADONG INTERNATIONAL COMPANY LTD.510(k) NO: K023662(TRADITIONAL) ATTN: MARIAN COCHRAN PHONE NO : 954-779-2500 501 S. ANDREWS AVE. SE DECISION MADE: 28-MAY-03 FT. LAUDERDALE, FL 33301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA HYCOR BIOMEDICAL LTD. 510(k) NO: K030741(TRADITIONAL) ATTN: DANIELLE M KNIGHT PHONE NO : 44 131 4457111 PENTLANDS SCIENCE PARK SE DECISION MADE: 01-MAY-03 BUSH LOAN 510(k) STATEMENT EDINBURGH, UNITED KINGDOM EH26 OPL DEVICE: HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM HYDROCISION, INC. 510(k) NO: K021813(TRADITIONAL) ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374 7 TIFFANY TRAIL SE DECISION MADE: 09-MAY-03 HOPKINTON, MA 01748 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTE HYPOGUARD USA, INC. 510(k) NO: K031388(SPECIAL) ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188 5182 WEST 76TH ST. SE DECISION MADE: 22-MAY-03 MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR IMC-HEARTWAY, LLC 510(k) NO: K030432(ABBREVIATED) ATTN: JUAN CARLOS RIVERA PHONE NO : 941-541-0330 6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 01-MAY-03 FORT MYERS, FL 33912 510(k) STATEMENT DEVICE: AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM IMMUNO CONCEPTS, N.A., LTD 510(k) NO: K030775(ABBREVIATED) ATTN: ERIC S HOY PHONE NO : 972-247-3616 2280 SPRINGLAKE RD. SE DECISION MADE: 12-MAY-03 SUITE 106 510(k) STATEMENT DALLAS, TX 75234 DEVICE: IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-009 IMPACT INSTRUMENTATION, INC. 510(k) NO: K022062(ABBREVIATED) ATTN: LESLIE H SHERMAN PHONE NO : 973-882-1212 27 FAIRFIELD PL. SE DECISION MADE: 06-MAY-03 P.O. BOX 508 510(k) SUMMARY AVAILABLE FROM FDA WEST CALDWELL, NJ 07006-0508 DEVICE: KALAZAR DETECT INBIOS INTL., INC. 510(k) NO: K023483(TRADITIONAL) ATTN: ESTELA I RAYCHAUDHURI PHONE NO : 206-344-5821 562 1ST. AVE. SOUTH, SUITE 600 SE DECISION MADE: 06-MAY-03 SEATTLE, WA 98104 510(k) STATEMENT DEVICE: COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR INGENJORSFIRMAN BJORN BERGDAHL AB 510(k) NO: K023733(ABBREVIATED) ATTN: BJORN BERGDAHL PHONE NO : 46 031 910787 HALLESAS 6452 SE DECISION MADE: 14-MAY-03 BILLDAL, SWEDEN SE 427 51 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INION OTPS BIODEGRADABLE MINI PLATING SYSTEM INION LTD. 510(k) NO: K023887(TRADITIONAL) ATTN: HANNA MARTTILA PHONE NO : 358 323 06600 LAAKARINKATU 2 SE DECISION MADE: 30-MAY-03 TAMPERE, FINLAND 33520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAEKOGEL MODELS EK 2000 & EK 2001 INMED LTDA. 510(k) NO: K030889(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 770-777-4146 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 23-MAY-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL FACTOR X DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. 510(k) NO: K031122(TRADITIONAL) ATTN: CAROL MARBLE PHONE NO : 781-861-4467 113 HARTWELL AVE. SE DECISION MADE: 19-MAY-03 LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 INTEGRA NEURO SCIENCES 510(k) NO: K031086(SPECIAL) ATTN: NANCY A MATHEWSON PHONE NO : 858-455-1115 5955 PACIFIC CENTER BLVD. SE DECISION MADE: 14-MAY-03 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERPORE CROSS CEMENT RESTRICTOR INTERPORE CROSS INTL. 510(k) NO: K023908(TRADITIONAL) ATTN: PROSIE REY-FESSLER PHONE NO : 949-453-3200 181 TECHNOLOGY DR. SE DECISION MADE: 16-MAY-03 IRVINE, CA 92618-2402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSATURA BCP BONE VOID FILLER ISOTIS NV 510(k) NO: K030131(TRADITIONAL) ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 20-MAY-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOME J. MORITA MFG. CORP. 510(k) NO: K030699(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K ST. N.W. SE DECISION MADE: 29-MAY-03 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH J. MORITA USA, INC. 510(k) NO: K030450(TRADITIONAL) ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K ST. N.W. SE DECISION MADE: 06-MAY-03 11TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: IN-VISION IMAGING SYSTEM JOMED, INC. 510(k) NO: K031148(SPECIAL) ATTN: LORRAINE W HUFFMAN PHONE NO : 916-638-9404 2870 KILGORE RD. SE DECISION MADE: 28-MAY-03 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,1 JOMED, INC. 510(k) NO: K031277(SPECIAL) ATTN: TERRY SCHULTZ PHONE NO : 858-673-0189 2870 KILGORE RD. SE DECISION MADE: 14-MAY-03 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3 KAVO AMERICA 510(k) NO: K030607(TRADITIONAL) ATTN: JENNIFER POTTALA PHONE NO : 800-323-8029 340 EAST MAIN ST. SE DECISION MADE: 02-MAY-03 LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BELLEGLASS POINT 4 KERR DENTAL MATERIALS CENTER 510(k) NO: K030646(TRADITIONAL) ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 06-MAY-03 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAC-MAC LIMITED INNERBLOC O.R. GOWN LAC MAC, LTD. 510(k) NO: K030536(TRADITIONAL) ATTN: JEFFREY O STULL PHONE NO : 512-288-8272 10907 WAREHAM COURT SE DECISION MADE: 06-MAY-03 AUSTIN, TX 78739 510(k) STATEMENT DEVICE: LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL LAC MAC, LTD. 510(k) NO: K031362(TRADITIONAL) ATTN: JEFFREY O STULL PHONE NO : 512-288-8272 10907 WAREHAM COURT SE DECISION MADE: 30-MAY-03 AUSTIN, TX 78739 510(k) STATEMENT DEVICE: OPAQUE HERRICK LACRIMAL PLUG LACRIMEDICS, INC. 510(k) NO: K030300(TRADITIONAL) ATTN: JERRY HENDERSON PHONE NO : 360-376-7095 310 PRUNE ALLEY SE DECISION MADE: 09-MAY-03 EASTSOUND, WA 98245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAREO RETRACTABLE SAFETY SYRINGE LIFE-SHIELD PRODUCTS, INC 510(k) NO: K030976(TRADITIONAL) ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 30-MAY-03 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS LUMENIS 510(k) NO: K030527(TRADITIONAL) ATTN: ANDREA L RUTH PHONE NO : 408-764-3000 2400 CONDENSA ST. SE DECISION MADE: 20-MAY-03 SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAPILLON MASK SET MAP MEDIZINTECHNIK FUR ARZT UND PA510(k) NO: K023068(TRADITIONAL) ATTN: ROGER KOTTER PHONE NO : 858-746-2282 14040 DANIELSON ST. SE DECISION MADE: 28-MAY-03 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE MASIMO CORP. 510(k) NO: K031330(SPECIAL) ATTN: JAMES J CRONIN PHONE NO : 949-250-9688 2852 KELVIN AVE. SE DECISION MADE: 12-MAY-03 IRVINE, CA 92614-5826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT MEDCOMP 510(k) NO: K030502(TRADITIONAL) ATTN: MEGHAN J TINTLE PHONE NO : 215-256-4201 1499 DELP DR. SE DECISION MADE: 20-MAY-03 HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LE MEDICAL ANALYSIS SYSTEMS, INC. 510(k) NO: K031364(TRADITIONAL) ATTN: PENNY M LAYMAN PHONE NO : 805-987-7891 5300 ADOLFO RD. SE DECISION MADE: 30-MAY-03 CAMARILLO, CA 93012 510(k) STATEMENT DEVICE: HERO MEDICAL DECISION NETWORKS 510(k) NO: K021230(TRADITIONAL) ATTN: WILLIAM E KING PHONE NO : 888-971-7953 2300 COMMONWEALTH DR. SE DECISION MADE: 09-MAY-03 CHARLOTTESVILLE, VA 22901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEADFIX MEDICAL INTELLIGENCE MEDIZINTECHNI510(k) NO: K030439(TRADITIONAL) ATTN: CORNELIA DAMSKY PHONE NO : 203-323-7535 56 WESTCOTT RD. SE DECISION MADE: 08-MAY-03 STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS MEDISON AMERICA, INC. 510(k) NO: K031552(TRADITIONAL) ATTN: BOB DEPALMA PHONE NO : 714-889-3070 11075 KNOTT AVE. SE DECISION MADE: 30-MAY-03 CYPRESS, CA 90630 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MSI SA ELECTRODES MEDSPHERE INTERNATIONAL, INC 510(k) NO: K030996(TRADITIONAL) ATTN: ERIC KAO PHONE NO : 510-656-8232 48511 WARM SPRINGS BLVD. SE DECISION MADE: 30-MAY-03 SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA FREMONT, CA 94539 DEVICE: MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM ("AURORA") MEDTRONIC AVE, INC. 510(k) NO: K030839(SPECIAL) ATTN: MARLENE COBB-CARLSON PHONE NO : 707-541-3052 3576 UNOCAL PLACE SE DECISION MADE: 30-MAY-03 SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K031037(SPECIAL) ATTN: RONALD W BENNETT PHONE NO : 612-391-9000 7611 NORTHLAND DR. SE DECISION MADE: 13-MAY-03 MINNEAPOLIS, MN 55428-1088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K030840(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 15-MAY-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K030932(SPECIAL) ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133 1800 PYRAMID PL. SE DECISION MADE: 16-MAY-03 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PACEART SYSTEM MEDTRONIC, INC. 510(k) NO: K024278(TRADITIONAL) ATTN: KAREN RUTH-JARMON PHONE NO : 763-514-3783 7000 CENTRAL AVE. N.E. SE DECISION MADE: 29-MAY-03 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 5071 MYOCARDIAL PACING LEAD MEDTRONIC, INC. 510(k) NO: K031274(SPECIAL) ATTN: TINA BENOIT PHONE NO : 763-514-4112 7000 CENTRAL AVENUE NE SE DECISION MADE: 22-MAY-03 MINNEAPOLIS, MN 55432-3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONI MEDTRONIC, INC. 510(k) NO: K031518(SPECIAL) ATTN: DAWN STENSTROM PHONE NO : 763-391-9000 7611 NORTHLAND DRIVE SE DECISION MADE: 22-MAY-03 MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K031285(TRADITIONAL) ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669 11506 SOUTH STATE ST. SE DECISION MADE: 19-MAY-03 DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 4951M MYOCARDIAL UNIPOLAR LEAD METRONIC, INC. 510(k) NO: K031210(SPECIAL) ATTN: TINA BENOIT PHONE NO : 763-514-4112 7000 CENTRAL AVE. N.E. SE DECISION MADE: 16-MAY-03 MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYS*STIM 208 AND 208A METTLER ELECTRONICS CORP. 510(k) NO: K031017(TRADITIONAL) ATTN: ROBERT E FLEMING PHONE NO : 714-533-2221 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 30-MAY-03 ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRI COTININE EIA ASSAY MICROGENICS CORP. 510(k) NO: K030649(TRADITIONAL) ATTN: LAKSHMI ANNE PHONE NO : 510-979-5023 46360 FREMONT BLVD. SE DECISION MADE: 22-MAY-03 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXOJET TISSUE MANAGEMENT SYSTEM MITEK WORLDWIDE 510(k) NO: K031406(TRADITIONAL) ATTN: SERGIO J GADALETA PHONE NO : 781-251-2018 A JOHNSON & JOHNSON COMPANY SE DECISION MADE: 30-MAY-03 249 VANDERBILT AVENUE 510(k) SUMMARY AVAILABLE FROM FDA NORWOOD, MA 02062 DEVICE: MODIFICATION TO TRUPEAK PEAK FLOW METER MONAGHAN MEDICAL CORP. 510(k) NO: K031514(SPECIAL) ATTN: JAMES A COCHIE PHONE NO : 518-561-7330 5 LATOUR AVE., SUITE 1600 SE DECISION MADE: 23-MAY-03 P.O. BOX 2805 510(k) STATEMENT PLATTSBURGH, NY 12901 DEVICE: PD CASTA-H MOUNTAIN MEDICO, INC. 510(k) NO: K030632(TRADITIONAL) ATTN: RUTH C JOLINE PHONE NO : 909-931-0688 600 NORTH MOUNTAIN AVE., #D204 SE DECISION MADE: 07-MAY-03 UPLAND, CA 91786 510(k) STATEMENT DEVICE: FYRELINK VL MPACS, LLC. 510(k) NO: K030728(TRADITIONAL) ATTN: GREG SOPOTNICK PHONE NO : 608-827-7111 7601 GANSER WAY SE DECISION MADE: 23-MAY-03 MADISON, WI 53719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYTHOS 500 MSQ (M2) LTD. 510(k) NO: K030805(TRADITIONAL) ATTN: ARAVA HACOHEN PHONE NO : 972 9 7718130 117 AHUZAH ST. SE DECISION MADE: 21-MAY-03 RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL MYTECH TECHNOLOGY CO., LTD. 510(k) NO: K030561(TRADITIONAL) ATTN: SHU CHEN CHENG PHONE NO : 614-451-1918 2064 TAMARIN DR. SE DECISION MADE: 09-MAY-03 COLUMBUS, OH 43235 510(k) STATEMENT DEVICE: MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST NASTECH PHARMACEUTICAL COMPANY, IN510(k) NO: K030443(TRADITIONAL) ATTN: PETER C APRILE PHONE NO : 631-273-0101 45 ADAMS AVE. SE DECISION MADE: 09-MAY-03 HAUPPAUGE, NY 11788-3605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 NDO SURGICAL, INC. 510(k) NO: K031262(SPECIAL) ATTN: ERIC BANNON PHONE NO : 508-337-8881 125 HIGH ST., SE DECISION MADE: 23-MAY-03 SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA MANSFIELD, MA 02048 DEVICE: OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N NELLCOR PURITAN BENNETT, INC. 510(k) NO: K030930(TRADITIONAL) ATTN: GINA TO PHONE NO : 925-463-4427 4280 HACIENDA DR. SE DECISION MADE: 23-MAY-03 PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARECOMPANION PATIENT STATION & NURSE STATION NEPTEC DESIGN GROUP, LTD. 510(k) NO: K022274(TRADITIONAL) ATTN: JOHN SCHNEIDER PHONE NO : 613 599 7602 302 LEGGET DR. SE DECISION MADE: 29-MAY-03 KANATA ONTARIO, CANADA K2K 1Y5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION NEPTEC DESIGN GROUP, LTD. 510(k) NO: K023286(TRADITIONAL) ATTN: JOHN SCHNEIDER PHONE NO : 613 599 7602 302 LEGGET DR. SE DECISION MADE: 02-MAY-03 KANATA, ONTARIO, CANADA K2K 1Y5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLTOUCH ND: YAG LASER SYSTEM NEW STAR LASERS, INC. 510(k) NO: K030453(TRADITIONAL) ATTN: DAVID R HENNINGS PHONE NO : 916-677-1975 9085 FOOTHILLS BLVD. SE DECISION MADE: 12-MAY-03 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOL TOUCH 3 NEW STAR LASERS, INC. 510(k) NO: K031184(SPECIAL) ATTN: DONALD V JOHNSON PHONE NO : 916-677-1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 21-MAY-03 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS NUMED, INC. 510(k) NO: K030589(SPECIAL) ATTN: NICHELLE R LAFLESH PHONE NO : 315-328-4491 2880 MAIN ST. SE DECISION MADE: 21-MAY-03 HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OLYMPIC CFM 6000 OLYMPIC MEDICAL CORP. 510(k) NO: K031149(SPECIAL) ATTN: EDWARD B. (TED) WEILER PHONE NO : 206-767-3500 5900 FIRST AVE., SOUTH SE DECISION MADE: 14-MAY-03 SEATTLE, WA 98108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 OLYMPUS OPTICAL CO., LTD. 510(k) NO: K031347(TRADITIONAL) ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688 TWO CORPORATE CENTER DR. SE DECISION MADE: 09-MAY-03 MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANA DETECT ORGENTEC DIAGNOSTIKA GMBH 510(k) NO: K030929(TRADITIONAL) ATTN: MICHAEL H FOLEY PHONE NO : 763-780-2955 8201 CENTRAL AVE. NE, SUITE P SE DECISION MADE: 02-MAY-03 MINNEAPOLIS, MN 55432 510(k) STATEMENT DEVICE: TENO FIX ORTHEON MEDICAL, LLC. 510(k) NO: K023594(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST. NW SE DECISION MADE: 15-MAY-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR ORTHOFIX, INC. 510(k) NO: K031219(SPECIAL) ATTN: MARY BIGGERS PHONE NO : 469-742-2561 1720 BRAY CENTRAL DR. SE DECISION MADE: 28-MAY-03 MCKINNEY, TX 75069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.2 ORTHOSOFT, INC. 510(k) NO: K030827(TRADITIONAL) ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074 75 QUEEN ST., SUITE 3300 SE DECISION MADE: 23-MAY-03 MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 ORTHOSOFT, INC. 510(k) NO: K031156(SPECIAL) ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074 75 QUEEN ST., SUITE 3300 SE DECISION MADE: 09-MAY-03 MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOMED 2.0 LOCKING PLATES AND SCREWS OSTEOMED L.P. 510(k) NO: K030448(TRADITIONAL) ATTN: DAWN T HOLDEMAN PHONE NO : 972-677-4600 3885 ARAPAHO RD. SE DECISION MADE: 09-MAY-03 ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFT-TOUCH TENS ELECTRODE PAIN MANAGEMENT TECHNOLOGIES 510(k) NO: K030375(TRADITIONAL) ATTN: JOSHUA LEFKOVITZ PHONE NO : 330-762-7474 43 E. MARKET ST. SE DECISION MADE: 05-MAY-03 AKRON, OH 44308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPAROSHIELD CONDITIONED INSUFFLATION SET PALL MEDICAL 510(k) NO: K030469(TRADITIONAL) ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH STREET, N.W. SE DECISION MADE: 09-MAY-03 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT PASCAL CO., INC. 510(k) NO: K012889(TRADITIONAL) ATTN: DAVID R JOY PHONE NO : 202-434-4100 1001 G STREET, N.W. SE DECISION MADE: 27-MAY-03 SUITE 500 WEST 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20001 DEVICE: FLUORILAQ PASCAL CO., INC. 510(k) NO: K030488(TRADITIONAL) ATTN: VINCENT M TENTARELLI PHONE NO : 425-827-4694 2929 N.E. NORTHUP WAY SE DECISION MADE: 02-MAY-03 BELLEVUE, WA 98004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. 510(k) NO: K030933(TRADITIONAL) ATTN: LINDA K SILLON PHONE NO : 303-423-9504 12750 WEST 42ND AVE. SE DECISION MADE: 01-MAY-03 WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEAK MOTUS PEAK PERFORMANCE TECHNOLOGIES, INC510(k) NO: K030714(TRADITIONAL) ATTN: LARRY SCHEIRMAN PHONE NO : 303-799-8686 7388 S. REVERE PKY 901 SE DECISION MADE: 16-MAY-03 CENTINNIAL, CO 80112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGNITY OPHTHALMIC SURGICAL SYSTEM PHACOR INC., A SANTEN COMPANY 510(k) NO: K031404(TRADITIONAL) ATTN: JEFF B PAUL PHONE NO : 805-546-1815 775 FIERO LN. SE DECISION MADE: 22-MAY-03 SAN LUIS OBISPO, CA 93401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LAR PHILIPS MEDICAL SYSTEMS 510(k) NO: K030417(TRADITIONAL) ATTN: PETER OHANIAN PHONE NO : 978-659-3397 3000 MINUTEMAN RD. SE DECISION MADE: 09-MAY-03 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K031333(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425-487-7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 13-MAY-03 P.O.BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA BOTHELL, WA 98041-3003 THIRD PARTY REVIEW DEVICE: M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K031403(SPECIAL) ATTN: DAVID OSBORN PHONE NO : 978-659-3178 3000 MINUTEMAN RD. SE DECISION MADE: 30-MAY-03 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RE PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K031481(SPECIAL) ATTN: HAUKE SCHIK PHONE NO : 49 703 14632031 HEWLETT-PACKARD STR.2 SE DECISION MADE: 29-MAY-03 BOBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLYCA-DIRECT FRUCTOSAMINE POLYMEDCO, INC. 510(k) NO: K023654(TRADITIONAL) ATTN: HELEN LANDICHO PHONE NO : 425-814-1514 510 FURNACE DOCK RD. SE DECISION MADE: 02-MAY-03 CORTLANDT MANOR, NY 10567 510(k) STATEMENT DEVICE: POWERLITE 600 EP SYSTEM PRESWEDE AB 510(k) NO: K030423(TRADITIONAL) ATTN: SUSAN GOLDSTEIN FALK PHONE NO : 463 348 8860 55 NORTHERN BLVD. SE DECISION MADE: 09-MAY-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 DEVICE: PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATI PRIMARY CARE SOLUTIONS, INC. 510(k) NO: K030813(TRADITIONAL) ATTN: RON MADDIX PHONE NO : 813-779-7226 40420 FREE FALL AVE. SE DECISION MADE: 30-MAY-03 ZEPHYRHILLS, FL 33540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL PROSURG, INC. 510(k) NO: K030631(TRADITIONAL) ATTN: ASHVIN DESAI PHONE NO : 408-945-4044 2195 TRADE ZONE BLVD. SE DECISION MADE: 19-MAY-03 SAN JOSE, CA 95131 510(k) STATEMENT DEVICE: MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFT PROXIMA THERAPEUTICS, INC. 510(k) NO: K030558(TRADITIONAL) ATTN: MARTINE D SCHNEIDER PHONE NO : 770-753-4848 2555 MARCONI DRIVE, SUITE 220 SE DECISION MADE: 21-MAY-03 ALPHARETTA, GA 30005-2066 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE PT. MANDIRI INTI BUANA 510(k) NO: K031020(TRADITIONAL) ATTN: NG POY SIN PHONE NO : 62 61 4566506 JL LISTRIK NO. 6 SE DECISION MADE: 21-MAY-03 MEDAN, INDONESIA 20112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATER PURIFICATION SYSTEM PURITY WATER COMPANY OF SAN ANTONI510(k) NO: K022448(TRADITIONAL) ATTN: BERT HUDSON PHONE NO : 210-497-0109 803 EVIAN SE DECISION MADE: 28-MAY-03 SAN ANTONIO, TX 78258 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARAMIS II DERMATOLOGICAL LASER QUANTEL MEDICAL 510(k) NO: K023734(TRADITIONAL) ATTN: ROGER W BARNES PHONE NO : 501-525-8612 342 SUNSET BAY RD. SE DECISION MADE: 06-MAY-03 HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIOMED SOFT TISSUE MARKER RADIOMED CORP. 510(k) NO: K031206(SPECIAL) ATTN: GORDON ROBERTS PHONE NO : 978-649-0300 ONE INDUSTRIAL WAY SE DECISION MADE: 21-MAY-03 TYNGSBORO, MA 01879 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX AMMONIA RANDOX LABORATORIES, LTD. 510(k) NO: K030873(TRADITIONAL) ATTN: LYNNE HAMILTON PHONE NO : 44 28 94 422413 55 DIAMOND RD. SE DECISION MADE: 12-MAY-03 CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT DEVICE: RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE RANFAC CORP. 510(k) NO: K031344(TRADITIONAL) ATTN: ANNETTE M FAGNANT PHONE NO : 401-392-0287 53 KENNEDY RD. SE DECISION MADE: 23-MAY-03 FOSTER, RI 02825 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPACS PRISM REAL TIME IMAGE INC. 510(k) NO: K030751(TRADITIONAL) ATTN: CARL ALLETTO PHONE NO : 940-300-8601 1100 LAKEVIEW BLVD. SE DECISION MADE: 29-MAY-03 DENTON, TX 76208 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL 510(k) NO: K031610(TRADITIONAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001 55 NORTHERN BLVD. SE DECISION MADE: 27-MAY-03 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GREAT NECK, NY 11021 THIRD PARTY REVIEW DEVICE: RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR RITA MEDICAL SYSTEMS INC 510(k) NO: K031257(TRADITIONAL) ATTN: VICKI HACKER PHONE NO : 650-314-3433 967 N. SHORELINE BLVD. SE DECISION MADE: 02-MAY-03 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING ROCHE DIAGNOSTICS CORP. 510(k) NO: K030845(TRADITIONAL) ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742 9115 HAGUE RD. SE DECISION MADE: 22-MAY-03 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS LH CALSET II ROCHE DIAGNOSTICS CORP. 510(k) NO: K031299(SPECIAL) ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 12-MAY-03 INDIANAPOLIS, IN 46250-0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSS EMBRACE ENTERAL PUMP ROSS PRODUCT DIV. ABBOTT LABORATOR510(k) NO: K031407(SPECIAL) ATTN: DANIEL HAMILTON PHONE NO : 614-624-3743 625 CLEVELAND AVE. SE DECISION MADE: 20-MAY-03 COLUMBUS, OH 43215-1724 510(k) STATEMENT DEVICE: EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP S-TCT HEALTH INC. 510(k) NO: K030587(TRADITIONAL) ATTN: JAMES S TURNER PHONE NO : 202-462-8800 1400 16TH STREET, NW SUITE 333 SE DECISION MADE: 30-MAY-03 WASHINGTON, DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CDR PANX, MODEL 4792 SCHICK TECHNOLOGIES, INC. 510(k) NO: K031291(TRADITIONAL) ATTN: DANIEL J SHERRATT PHONE NO : 718-482-2159 30-00 47TH AVE. SE DECISION MADE: 05-MAY-03 LONG ISLAND CITY, NY 11101 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO EASYS TRANSVERSE CONNECTION SCIENT'X USA, INC. 510(k) NO: K031290(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 13-MAY-03 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIV SELECTIVE MED COMPONENTS, INC. 510(k) NO: K031053(TRADITIONAL) ATTN: RICHARD J FISHER PHONE NO : 740-397-7838 201 WEST HIGH ST. SE DECISION MADE: 20-MAY-03 MOUNT VERNON, OH 43050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 SHANGHAI MOTEX HEALTHCARE CO., LTD510(k) NO: K030207(TRADITIONAL) ATTN: TONY T.K. CHENG PHONE NO : 86 21 59799888 NO.6318, FANG HUANG RD, HUAXIN SE DECISION MADE: 02-MAY-03 QINGPU, SHANGHAI, CHINA 201708 510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E SHANGHAI PALOMAR MOUNTAIN INDUSTRI510(k) NO: K031072(TRADITIONAL) ATTN: PHONE NO : 18709 GREEN BAY DR. SE DECISION MADE: 06-MAY-03 ROWLAND HIGHS, CA 91748 510(k) STATEMENT DEVICE: SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE SHIJIAZHUANG EVERSHARP PLASTIC PRO510(k) NO: K031293(TRADITIONAL) ATTN: JAMES CHU PHONE NO : 714-990-6888 590 W. CENTRAL AVE. #D SE DECISION MADE: 09-MAY-03 BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM SIGMA VISION, INC. 510(k) NO: K030544(TRADITIONAL) ATTN: OMID KIA PHONE NO : 301-770-0052 6001 MONTROSE RD. STE. 606 SE DECISION MADE: 21-MAY-03 ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CALLOS SKELETAL KINETICS, LLC 510(k) NO: K030554(TRADITIONAL) ATTN: HOWARD HOLSTEIN PHONE NO : 202-637-5813 555 13TH ST. N.W. SE DECISION MADE: 20-MAY-03 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS II TOTAL KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K030612(ABBREVIATED) ATTN: KIM P KELLEY PHONE NO : 901-399-6566 1450 E. BROOKS RD. SE DECISION MADE: 27-MAY-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K030623(ABBREVIATED) ATTN: GINO J ROUSS PHONE NO : 901-399-6707 1450 E. BROOKS RD. SE DECISION MADE: 22-MAY-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM SMITH & NEPHEW, INC. 510(k) NO: K031162(SPECIAL) ATTN: KANU VADODARIA PHONE NO : 901-399-6261 1450 E. BROOKS RD. SE DECISION MADE: 01-MAY-03 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPHYRE BIPOLAR ABLATION PROBES SMITH & NEPHEW, INC. 510(k) NO: K031371(TRADITIONAL) ATTN: LINDA GUTHRIE PHONE NO : 650-687-2629 3700 HAVEN COURT SE DECISION MADE: 23-MAY-03 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 72 SMITH & NEPHEW, INC. 510(k) NO: K031379(SPECIAL) ATTN: JANICE HASELTON PHONE NO : 978-749-1494 150 MINUTEMAN RD. SE DECISION MADE: 22-MAY-03 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER SONOMEDICA 510(k) NO: K023759(TRADITIONAL) ATTN: SAILOR MOHLER PHONE NO : 703-448-4314 8230 LEESBURG PIKE SE DECISION MADE: 06-MAY-03 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA VIENNA, VA 22182 DEVICE: SR-130 SOURCE-RAY, INC. 510(k) NO: K030494(TRADITIONAL) ATTN: RAY MANEZ PHONE NO : 631-244-8200 167 KEYLAND CT. SE DECISION MADE: 20-MAY-03 BOHEMIA, NY 11716 510(k) STATEMENT DEVICE: SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR SPS MEDICAL SUPPLY CORP. 510(k) NO: K030680(TRADITIONAL) ATTN: GARY J SOCOLA PHONE NO : 585-359-0130 6789 WEST HENRIETTA RD. SE DECISION MADE: 09-MAY-03 RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: STARCAST DENTAL ALLOYS STAR REFINING PRECIOUS METALS SOUT510(k) NO: K031543(TRADITIONAL) ATTN: YOLANDA SMITH PHONE NO : 888-729-9674 PO BOX 4341 SE DECISION MADE: 30-MAY-03 CROFTON, MD 21114 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: EVERSTICK POST STICK TECH LTD. 510(k) NO: K030820(TRADITIONAL) ATTN: WILLIAM TROETEL PHONE NO : 914-664-1640 80 PARKWAY WEST SE DECISION MADE: 20-MAY-03 MOUNT VERNON, NY 10552 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER PAINPUMP2 STRYKER INSTRUMENTS 510(k) NO: K030661(TRADITIONAL) ATTN: NICOLE PETTY PHONE NO : 269-323-7700 4100 EAST MILHAM AVE. SE DECISION MADE: 30-MAY-03 KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMI SUN BIOMEDICAL LABORATORIES, INC. 510(k) NO: K023648(TRADITIONAL) ATTN: MING SUN PHONE NO : 856-401-1080 604 VPR CENTER SE DECISION MADE: 06-MAY-03 1001 LOWER LANDING RD. 510(k) SUMMARY AVAILABLE FROM FDA BLACKWOOD, NJ 08012 DEVICE: SUNPEX TECHNOLOGIES MODEL PW SUNPEX TECHNOLOGY CO., LTD. 510(k) NO: K024175(ABBREVIATED) ATTN: LEONARD FRIER PHONE NO : 410-354-3300 914 WEST PATAPSCO AVE. SE DECISION MADE: 01-MAY-03 BALTIMORE, MD 21230 510(k) STATEMENT DEVICE: QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 SUNRISE MEDICAL, INC. 510(k) NO: K031289(SPECIAL) ATTN: MICHAEL CHELLSON PHONE NO : 303-218-4925 7477 EAST DRY CREEK PKWY. SE DECISION MADE: 09-MAY-03 LONGMONT, CO 80503 510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR SYNMERTEX CO, LTD 510(k) NO: K031076(TRADITIONAL) ATTN: ALBERT LING PHONE NO : 909-465-5769 1404 GREENPORT AVE. SE DECISION MADE: 23-MAY-03 ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES SYNMERTEX CO, LTD 510(k) NO: K031120(TRADITIONAL) ATTN: ALBERT LING PHONE NO : 909-465-5769 1404 GREENPORT AVE. SE DECISION MADE: 23-MAY-03 ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT DEVICE: DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES SYNMERTEX CO, LTD 510(k) NO: K031171(TRADITIONAL) ATTN: ALBERT LING PHONE NO : 909-465-5769 1404 GREENPORT AVE. SE DECISION MADE: 23-MAY-03 ROWLAND HEIGHTS, CA 91748 510(k) STATEMENT DEVICE: SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATE SYNTHES (USA) 510(k) NO: K031178(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 05-MAY-03 PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA) 510(k) NO: K031508(TRADITIONAL) ATTN: LISA M BOYLE PHONE NO : 610-647-9700 1690 RUSSELL RD. SE DECISION MADE: 30-MAY-03 POST OFFICE BOX 1766 510(k) SUMMARY AVAILABLE FROM FDA PAOLI, PA 19301 DEVICE: TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULI TAIJECT MEDICAL DEVICE CO., LTD. 510(k) NO: K031062(SPECIAL) ATTN: JIM-SON CHOU PHONE NO : 949-294-6458 P.O. BOX 8853 SE DECISION MADE: 02-MAY-03 NEWPORT BEACH, CA 92658 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTA MODEL D RETINAL THICKNESS ANALYZER TALIA TECHNOLOGY LTD. 510(k) NO: K031312(SPECIAL) ATTN: JONATHAN S KAHN PHONE NO : 202-637-5794 555 THIRTEENTH ST. N.W. SE DECISION MADE: 06-MAY-03 WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPIOX CARDIOTOMY RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K030505(TRADITIONAL) ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 14-MAY-03 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURSHIELD SAFETY WINGED INFUSION SET TERUMO CORP. 510(k) NO: K031266(TRADITIONAL) ATTN: BARBARA SMITH PHONE NO : 410-392-7241 125 BLUE BALL RD. SE DECISION MADE: 30-MAY-03 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURSHIELD SAFETY WINGED BLOOD COLLECTION SET TERUMO MEDICAL PRODUCTS HANGZHOU C510(k) NO: K031279(TRADITIONAL) ATTN: KAZUHITO INOUE PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 30-MAY-03 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: "ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II" THE ANSPACH EFFORT, INC. 510(k) NO: K030576(TRADITIONAL) ATTN: WILLIAM G CONETY PHONE NO : 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 21-MAY-03 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAHURKAR OPLUS CATHETER, MODEL 13.5 FR THE KENDALL COMPANY 510(k) NO: K030209(TRADITIONAL) ATTN: REGINA YEH PHONE NO : 508-261-8404 15 HAMPSHIRE ST. SE DECISION MADE: 13-MAY-03 MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATHWAY STM-10 PELVIC FLOOR STIMULATOR THE PROMETHEUS GROUP 510(k) NO: K030039(TRADITIONAL) ATTN: PETER SULLIVAN PHONE NO : 781-582-2328 2 MALLARDS COVE SE DECISION MADE: 23-MAY-03 DUXBURY, MA 02332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERMACOOL TC SYSTEM THERMAGE, INC. 510(k) NO: K031046(SPECIAL) ATTN: PAMELA M BUCKMAN PHONE NO : 510-782-2286 4058 POINT EDEN WAY SE DECISION MADE: 22-MAY-03 HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOKUYAMA SOFRELINER TOUGH TOKUYAMA DENTAL CORPORATION 510(k) NO: K030663(TRADITIONAL) ATTN: DANIEL J MANELLI PHONE NO : 202-261-1000 2000 M ST. N.W. 7TH FLOOR SE DECISION MADE: 29-MAY-03 WASHINGTON, DC 20036-3307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HLS UNI EVOLUTION PROSTHESIS TORNIER S.A. 510(k) NO: K022211(TRADITIONAL) ATTN: MIREILLE LEMERY PHONE NO : 330 476 613500 ZIRST-161, RUE LAVOISIER SE DECISION MADE: 22-MAY-03 MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS TORNIER S.A. 510(k) NO: K031218(SPECIAL) ATTN: MIREILLE LEMERY PHONE NO : 33 4 76613500 ZIRST-161, RUE LAVOISIER SE DECISION MADE: 16-MAY-03 MONTBONNOT, FRANCE 38330 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K031469(TRADITIONAL) ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 22-MAY-03 P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA TUSTIN, CA 92781-2068 THIRD PARTY REVIEW DEVICE: CLEARBLUE EASY DIGITAL PREGNANCY TEST UNIPATH LTD. 510(k) NO: K030659(TRADITIONAL) ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564 PRIORY BUSINESS PARK SE DECISION MADE: 02-MAY-03 BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT DEVICE: PRIMA III TOTALSENSE TORSO COIL USA INSTRUMENTS, INC. 510(k) NO: K030371(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 05-MAY-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. 510(k) NO: K031056(SPECIAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 08-MAY-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PREMIER III PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. 510(k) NO: K031139(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 29-MAY-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHA 5000 WRIST COIL USA INSTRUMENTS, INC. 510(k) NO: K031143(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 29-MAY-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRIT III TOTALSENSE CARDIAC COIL USA INSTRUMENTS, INC. 510(k) NO: K031172(TRADITIONAL) ATTN: CHRISTIE SHUMAKER PHONE NO : 330-562-1000 1515 DANNER DR. SE DECISION MADE: 29-MAY-03 AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 VALLEYLAB, INC. 510(k) NO: K031011(TRADITIONAL) ATTN: HERBERT VINSON PHONE NO : 303-530-6469 5920 LONGBOW DR. SE DECISION MADE: 29-MAY-03 BOULDER, CO 80301-3299 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VAPOTHERM 2000H VAPOTHERM, INC. 510(k) NO: K013486(TRADITIONAL) ATTN: PAUL E DRYDEN PHONE NO : 317-335-3780 6329 W.WATERVIEW CT. SE DECISION MADE: 30-MAY-03 MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARISEED 7.1 VARIAN MEDICAL SYSTEMS 510(k) NO: K030534(TRADITIONAL) ATTN: LINDA S NASH PHONE NO : 650-424-6990 3100 HANSEN WAY SE DECISION MADE: 21-MAY-03 PALO ALTO, CA 94304-1038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSVAGINAL DOPPLER PROBE VASCULAR CONTROL SYSTEMS, INC 510(k) NO: K031358(TRADITIONAL) ATTN: KATHLEEN ROBERTS PHONE NO : 949-488-8700 32236 PASEO ADELANTO, STE. E SE DECISION MADE: 09-MAY-03 SAN JUAN CAPISTRANO, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: T.E.A.R. TECH3 MODEL #44TT03 VISION QUEST INDUSTRIES, INC. 510(k) NO: K030507(TRADITIONAL) ATTN: ALAN WADE PHONE NO : 949-261-3000 18011 MITCHELL SO. SE DECISION MADE: 20-MAY-03 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY W.L. GORE & ASSOCIATES,INC 510(k) NO: K031089(SPECIAL) ATTN: TRACY DE VAN WOLF PHONE NO : 302-292-5081 750 OTT'S CHAPEL RD. SE DECISION MADE: 08-MAY-03 NEWARK, DE 19713 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIN DOWN RAPIDFLAP WALTER LORENZ SURGICAL, INC. 510(k) NO: K031034(SPECIAL) ATTN: KIM REED PHONE NO : 904-741-4400 1520 TRADEPORT DR. SE DECISION MADE: 21-MAY-03 JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURETEMP PLUS WELCH ALLYN, INC. 510(k) NO: K030580(TRADITIONAL) ATTN: DEBRA L JACKSON PHONE NO : 858-635-6081 7420 CARROLL RD. SE DECISION MADE: 06-MAY-03 SAN DIEGO, CA 92121-2334 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 WESTERN CLINICAL TECHNOLOGY SYSTEM510(k) NO: K023230(TRADITIONAL) ATTN: W.T. WORKMAN PHONE NO : 210-490-6999 18111 COPPER RIDGE DR. SE DECISION MADE: 05-MAY-03 SAN ANTONIO, TX 78259 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITTLE COACH WHEELCHAIR & SCOOTER EXPRESS 510(k) NO: K030759(TRADITIONAL) ATTN: CHRIS TINSLEY PHONE NO : 620-325-2629 4905 A. SAN JACINTO SE DECISION MADE: 01-MAY-03 HOUSTON, TX 77004 510(k) STATEMENT DEVICE: MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYST WIDEMED LTD 510(k) NO: K022506(TRADITIONAL) ATTN: DAVID SOLOMON PHONE NO : 617-527-2227 OMER INDUSTRIAL PARK, BLDG 8C SE DECISION MADE: 15-MAY-03 POB 3002 510(k) SUMMARY AVAILABLE FROM FDA OMER, ISRAEL 84965 DEVICE: WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE WILSON-COOK MEDICAL, INC. 510(k) NO: K030618(TRADITIONAL) ATTN: MARGARET J POSNER PHONE NO : 336-744-0157 4900 BETHANIA STATION RD. SE DECISION MADE: 27-MAY-03 WINSTON-SALEM, NC 27105-4191 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: READI-LOAD SYSTEM, MODEL PSS 1820RL WORLDWIDE MEDICAL TECHNOLOGIES, IN510(k) NO: K022389(TRADITIONAL) ATTN: RICK TERWILLIGER PHONE NO : 203-263-2579 426 MAIN ST. NORTH SE DECISION MADE: 06-MAY-03 WOODBURY, CT 06798-0505 510(k) STATEMENT DEVICE: FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), ( X-CEL CONTACTS, A WALMAN CO. 510(k) NO: K030593(TRADITIONAL) ATTN: MARTIN DALSING PHONE NO : 970-243-5490 623 GLACIER DR. SE DECISION MADE: 30-MAY-03 GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYCUP ZER HITECH 510(k) NO: K023823(TRADITIONAL) ATTN: JAY MANSOUR PHONE NO : 678-908-8180 1308 MORNINGSIDE PARK DR. SE DECISION MADE: 22-MAY-03 ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES ZIMMER, INC. 510(k) NO: K030733(TRADITIONAL) ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523 P.O. BOX 708 SE DECISION MADE: 01-MAY-03 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 280 TOTAL WITH SUMMARIES 237 TOTAL WITH STATEMENTS 43
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