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Medical Devices
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May 2003 510(k) Clearances
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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