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Medical Devices
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November 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-NOV-2003 THROUGH 30-NOV-2003
DEVICE: PROTEMP 3 GARANT
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K033022(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 21-NOV-03
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
ACON LABORATORIES, INC. 510(k) NO: K033041(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 21-NOV-03
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR I
ADAPTIVE HEALTHCARE TECHNOLOGIES, 510(k) NO: K032879(TRADITIONAL)
ATTN: JOAN JOHNSON PHONE NO : 508-420-5035
P.O. BOX 614 SE DECISION MADE: 13-NOV-03
MARSTONS MILLS, MA 02648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
ADVANCED CIRCULATORY SYSTEMS, INC. 510(k) NO: K033401(SPECIAL)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 20-NOV-03
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATR 5000, LC 5000, IMPLANT SYSTEM
ADVANCED TECHNOLOGY RESEARCH (A.T. 510(k) NO: K033597(TRADITIONAL)
ATTN: DANIELE POLI PHONE NO : 390 573 364254
VIA GIOVANNI VERGA, 7 SE DECISION MADE: 25-NOV-03
PISTOIA, ITALY 51100 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: THERATEARS CONTACT LENS COMFORT DROPS
ADVANCED VISION RESEARCH, INC. 510(k) NO: K032481(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978-658-6888
269A BALLARDVALE STREET SE DECISION MADE: 04-NOV-03
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERONEB GO NEBULIZER, MODEL AG-AG2000
AEROGEN, INC. 510(k) NO: K032849(TRADITIONAL)
ATTN: NANCY E ISAAC PHONE NO : 650-864-7493
2071 STIERLIN COURT SE DECISION MADE: 21-NOV-03
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MDIFICATION TO MEDIPRIME
ALGOTEC SYSTEMS, LTD. 510(k) NO: K033013(SPECIAL)
ATTN: ELI M ORBACH PHONE NO : 972 2 9932768
P.O. BOX 6718 SE DECISION MADE: 25-NOV-03
EFRAT, ISRAEL 90435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
ALVEOLUS, INC. 510(k) NO: K032744(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609-924-9510
401 NORTH TRYON ST. SE DECISION MADE: 13-NOV-03
10TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CHARLOTTE, NC 28202
DEVICE: AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
ANALOGIC CORP. 510(k) NO: K033345(SPECIAL)
ATTN: MARVIN ROSENBAUM PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 19-NOV-03
PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEEDLYSER INFUSION CATHETER KIT
ANGIODYNAMICS, INC. 510(k) NO: K033443(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 19-NOV-03
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: ANZAI AZ-733 RESPIRATORY GATING SYSTEM
ANZAI MEDICAL CO, LTD. 510(k) NO: K031385(TRADITIONAL)
ATTN: T. WHIT ATHEY PHONE NO : 301-570-0013
2305 GOLD MINE RD. SE DECISION MADE: 10-NOV-03
BROOKEVILLE, MD 20833-2233 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-
AOMORI OLYMPUS CO., LTD. 510(k) NO: K033333(SPECIAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
2 CORPORATE CENTER DR. SE DECISION MADE: 14-NOV-03
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATA
ARCADIA MEDICAL CORPORATION 510(k) NO: K031553(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 18-NOV-03
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL
ARROW INTL., INC. 510(k) NO: K031153(TRADITIONAL)
ATTN: WILLIAM G MCLAIN PHONE NO : 610-378-0131
2400 BERNVILLE RD. SE DECISION MADE: 25-NOV-03
READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
ARTHREX, INC. 510(k) NO: K031666(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
2885 SOUTH HORSESHOE DR. SE DECISION MADE: 18-NOV-03
NAPLES, FL 34104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K033584(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 28-NOV-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTELON SURGICAL SUTURE
ARTIMPLANT AB 510(k) NO: K032160(TRADITIONAL)
ATTN: RUSS PAGANO PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 17-NOV-03
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM BIOLASER LLLT SERIES-3
AXIOM USA. INC 510(k) NO: K033015(TRADITIONAL)
ATTN: JIM GIBSON PHONE NO : 813-249-6444
9423 CORPORATE LAKE DRIVE SE DECISION MADE: 25-NOV-03
TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
BAUSCH & LOMB, INC. 510(k) NO: K031646(TRADITIONAL)
ATTN: PAUL G STAPLETON PHONE NO : 585-338-8172
1400 NORTH GOODMAN ST. SE DECISION MADE: 14-NOV-03
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q
BAXTER HEALTHCARE CORP. 510(k) NO: K031676(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN RD., MPR-A2E SE DECISION MADE: 20-NOV-03
MCGAW PARK, IL 60085-6730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
BAYER DIAGNOSTICS CORP. 510(k) NO: K033007(TRADITIONAL)
ATTN: KENNETH T EDDS PHONE NO : 914-524-2446
511 BENEDICT AVE. SE DECISION MADE: 14-NOV-03
TARRYTOWN, NY 10591-5097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
BECTON DICKINSON & CO. 510(k) NO: K033350(SPECIAL)
ATTN: M. WENDY BALLESTEROS PHONE NO : 201-847-6280
1 BECTON DRIVE SE DECISION MADE: 18-NOV-03
FRANKLIN LAKES, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
BESMED HEALTH BUSINESS CORP. 510(k) NO: K031374(TRADITIONAL)
ATTN: DR. JEN KE MIN PHONE NO : 720-962-5412
58 FU-CHIUN ST. SE DECISION MADE: 28-NOV-03
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-58
BESMED HEALTH BUSINESS CORP. 510(k) NO: K031375(TRADITIONAL)
ATTN: DR. JEN KE MIN PHONE NO : 720-962-5412
58 FU-CHIUN ST. SE DECISION MADE: 20-NOV-03
HSIN CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: HBA SPERM-HYALURONAN BINDING ASSAY
BIO-COAT, INC. 510(k) NO: K032874(TRADITIONAL)
ATTN: JAMES B JOHNSTON PHONE NO : 215-572-8977
455 PENNSYLVANIA AVE. SE DECISION MADE: 24-NOV-03
SUITE 120 510(k) STATEMENT
FORT WASHINGTON, PA 19034
DEVICE: INVISIJECT RESUSABLE AUTO-INJECTOR
BIOGEN 510(k) NO: K032425(TRADITIONAL)
ATTN: MICHAEL POIRIER PHONE NO : 617-679-6459
14 CAMBRIDGE CENTER SE DECISION MADE: 05-NOV-03
CAMBRIDGE, MA 02142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM NEGATIVE GATIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K032788(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM DR. SE DECISION MADE: 04-NOV-03
HAZELWOOD, MO 63042-2320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
BIOMERIEUX, INC. 510(k) NO: K032861(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 12-NOV-03
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIGEN PSI BONE GRAFT SUBSTITUTE
BIOMET ORTHOPEDICS, INC. 510(k) NO: K032286(TRADITIONAL)
ATTN: TRACY J BICKEL PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 20-NOV-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BI-ANGULAR SHOULDER SYSTEM
BIOMET, INC. 510(k) NO: K032895(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 20-NOV-03
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: LACTOSORB TIBIAL L-15 SCREW AND WASHER
BIOMET, INC. 510(k) NO: K033233(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 BELL DR. SE DECISION MADE: 05-NOV-03
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: UNIMARK HOME PREGNANCY TEST DEVICE
BIOTECH ATLANTIC, INC. 510(k) NO: K032992(TRADITIONAL)
ATTN: FRANCIS L DENG PHONE NO : 732-389-4789
BAY F, 6 INDUSTRIAL WAY WEST SE DECISION MADE: 21-NOV-03
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCOUT PRO
BIOTRONIK, INC. 510(k) NO: K033320(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN RD. SE DECISION MADE: 19-NOV-03
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BISCEM GI
BISCO, INC. 510(k) NO: K032597(TRADITIONAL)
ATTN: KATHY JOUNG PHONE NO : 847-534-6106
1100 WEST IRVING PARK RD. SE DECISION MADE: 04-NOV-03
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
BOSTON BIOMEDICA, INC. 510(k) NO: K032713(TRADITIONAL)
ATTN: PATRICIA E GARRETT PHONE NO : 508-580-1900
375 WEST ST. SE DECISION MADE: 24-NOV-03
WEST BRIDGEWATER, MA 02379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K033441(SPECIAL)
ATTN: HEIDI M ERICKSON PHONE NO : 763-494-2564
ONE BOSTON SCIENTIFIC PL. SE DECISION MADE: 21-NOV-03
NATICK, MA 01760-1537 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CON
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K032938(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 20-NOV-03
BATU BELAH 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) C
BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K032940(TRADITIONAL)
ATTN: G. BASKARAN PHONE NO : 603 334 31007
LOT 1559, JALAN ISTIMEWA, SE DECISION MADE: 20-NOV-03
BATU BELAH 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
BRUNO INDEPENDENT LIVING AIDS, INC 510(k) NO: K033438(SPECIAL)
ATTN: RICHARD KELLER PHONE NO : 262-953-5336
1780 EXECUTIVE DR. SE DECISION MADE: 20-NOV-03
P.O. BOX 84 510(k) STATEMENT
OCONOMOWOC, WI 53066
DEVICE: BARD ENDOTRACHEAL TUBE, CUFFED
C.R. BARD, INC. 510(k) NO: K030792(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 770-784-6257
8195 INDUSTRIAL BLVD. SE DECISION MADE: 14-NOV-03
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD DUAL LUMEN URETERAL CATHETER
C.R. BARD, INC. 510(k) NO: K032521(TRADITIONAL)
ATTN: FRANCES HARRISON PHONE NO : 770-784-6160
8195 INDUSTRIAL BLVD. SE DECISION MADE: 14-NOV-03
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
C.R. BARD, INC. 510(k) NO: K033245(SPECIAL)
ATTN: MICHAEL A PATZ PHONE NO : 978-262-4868
129 CONCORD RD., BLDG. #3 SE DECISION MADE: 06-NOV-03
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19
C.R. BARD, INC. 510(k) NO: K033294(SPECIAL)
ATTN: GLENN NORTON PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 26-NOV-03
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH N
CANOPUS MEDICAL SUPPLY CO., LTD. 510(k) NO: K023452(TRADITIONAL)
ATTN: RUBY LIN PHONE NO : 011 886 227162107
201 FU-HSING NORTH RD., 10TH SE DECISION MADE: 20-NOV-03
FL. 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 105
DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND U
CARDINAL HEALTH 510(k) NO: K032444(TRADITIONAL)
ATTN: ERICA SETHI PHONE NO : 847-785-3337
1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 13-NOV-03
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPC BAND
CENTER FOR ORTHOTIC AND PROSTHETIC 510(k) NO: K021594(TRADITIONAL)
ATTN: JOSEPH TERPENNING PHONE NO : 703-220-4274
2525 NORTH TENTH ST. #804 SE DECISION MADE: 13-NOV-03
ARLINGTON, VA 22201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSTEM 100 ULTRAFILTRATION CATHETER
CHF SOLUTIONS, INC. 510(k) NO: K023874(TRADITIONAL)
ATTN: AMY PETERSON PHONE NO : 763-463-4620
SUITE 170-7601 NORTHLAND DR. SE DECISION MADE: 20-NOV-03
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
CLEAR MEDICAL, INC. 510(k) NO: K033593(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 20-NOV-03
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED SINGLE USE DEVICES EP CATHETERS
CLEAR MEDICAL, INC. 510(k) NO: K033595(TRADITIONAL)
ATTN: MIKE KOVACS PHONE NO : 425-401-1414
1776 136TH PL. NE SE DECISION MADE: 26-NOV-03
BELLEVUE, WA 98005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAC HEMOGLOBIN A1C REAGENT KIT
CLINICAL DATA, INC. 510(k) NO: K031042(TRADITIONAL)
ATTN: WYNN STOCKING PHONE NO : 714-672-3553
1075 WEST LAMBERT ROAD SE DECISION MADE: 03-NOV-03
BREA, CA 92821-2944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUTTAFLOW
COLTENE/WHALEDENT GMBH & CO. KG 510(k) NO: K032662(TRADITIONAL)
ATTN: HENRY J VOGELSTEIN PHONE NO : 330-916-8800
235 ASCOT PARKWAY SE DECISION MADE: 03-NOV-03
CUYAHOGA FALLS, OH 44223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KWIKEZE MALE CONDOM APPLICATOR
CONDAX LLC. 510(k) NO: K031007(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919-544-4098
1219 LITTLE CREEK RD. SE DECISION MADE: 14-NOV-03
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHOCONNEX COMMUNICATOR
CONNEXMD 510(k) NO: K033093(TRADITIONAL)
ATTN: CURTIS LEBLEU PHONE NO : 206-850-5075
8536 18TH AVENUE NW SE DECISION MADE: 05-NOV-03
SEATTLE, WA 98117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK CODA BALLOON CATHETER
COOK, INC. 510(k) NO: K032869(TRADITIONAL)
ATTN: THEODORE HEISE PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 19-NOV-03
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOC'S BEST WHITE COPPER CEMENT
COOLEY & COOLEY, LTD. 510(k) NO: K031494(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101-A CULLEN BLVD. SE DECISION MADE: 12-NOV-03
HOUSTON, TX 77047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCLEAR COMPATIBLES MULTIFOCAL
COOPER VISION, INC. 510(k) NO: K032873(TRADITIONAL)
ATTN: LISA HAHN PHONE NO : 757-664-2421
1215 BOISSEVAIN AVE. SE DECISION MADE: 07-NOV-03
NORFOLK, VA 23507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
CTI PET SYSTEMS, INC. 510(k) NO: K033431(SPECIAL)
ATTN: WILLIAM SKREMSKY PHONE NO : 865-218-2522
810 INNOVATION DR. SE DECISION MADE: 20-NOV-03
KNOXVILLE, TN 37932-2571 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
CURELIGHT LTD 510(k) NO: K032383(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, N.W. SE DECISION MADE: 28-NOV-03
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE PHOTOGENICA SV LASER
CYNOSURE, INC. 510(k) NO: K032539(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 17-NOV-03
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
DADE BEHRING, INC. 510(k) NO: K032697(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 07-NOV-03
P.O. BOX 6101, BUILDING 500 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: MICROSCAN RAPID/S PLUS GRAM NEGATIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K033482(SPECIAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 26-NOV-03
WEST SACRAMENTO, CA 95691 510(k) STATEMENT
DEVICE: DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03
DATEX-OHMEDA 510(k) NO: K033281(TRADITIONAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM RD. SE DECISION MADE: 26-NOV-03
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
DEFIBTECH, LLC 510(k) NO: K033144(TRADITIONAL)
ATTN: JOHN L ROGERS PHONE NO : 203-453-6654
753 BOSTON POST RD., SUITE 102 SE DECISION MADE: 13-NOV-03
GUILFORD, CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENTATUS OSCIOMAT
DENTATUS USA, LTD. 510(k) NO: K031793(TRADITIONAL)
ATTN: RICHARD C LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 13-NOV-03
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: CONTEC DUO, CONTEC LC, CONTEC LCR
DENTAURUM 510(k) NO: K030644(TRADITIONAL)
ATTN: JAN W A DOORSCHODT PHONE NO : 215-968-2858
10 PHEASANT RUN SE DECISION MADE: 21-NOV-03
NEWTOWN, PA 18940 510(k) STATEMENT
DEVICE: DELTA SHOULDER
DEPUY, INC. 510(k) NO: K021478(TRADITIONAL)
ATTN: JANET G JOHNSON PHONE NO : 574-371-4907
700 ORTHOPAEDIC DR. SE DECISION MADE: 18-NOV-03
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
DEPUY, INC. 510(k) NO: K033329(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4944
P.O. BOX 988 SE DECISION MADE: 14-NOV-03
700 ORTHOPAEDIC DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
DEROYAL 510(k) NO: K033057(TRADITIONAL)
ATTN: SHARON COOK PHONE NO : 865-362-6157
200 DEBUSK LN. SE DECISION MADE: 20-NOV-03
POWELL, TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DGH 55 HANDHELD PACHYMETER (PACHMATE)
DGH TECHNOLOGY, INC. 510(k) NO: K033385(TRADITIONAL)
ATTN: M. LUTHER DETWEILER PHONE NO : 610-594-9100
110 SUMMIT DR., SUITE B SE DECISION MADE: 07-NOV-03
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
DIAMOND DIAGNOSTICS, INC. 510(k) NO: K033061(TRADITIONAL)
ATTN: LINDA M STUNDTNER PHONE NO : 508-429-0450
331 FISKE ST. SE DECISION MADE: 07-NOV-03
HOLLISTON, MA 01746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAEGER MICRO2+ AND MASIMO MINISAT
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K032537(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 25-NOV-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSULTIVA CASE INPUT STATION, MODEL CIS-1
EASTMAN KODAK COMPANY 510(k) NO: K031132(TRADITIONAL)
ATTN: WIDO MENHARDT PHONE NO : 408-858-0718
100 CENTURY CENTER COURT SUITE SE DECISION MADE: 26-NOV-03
600 510(k) SUMMARY AVAILABLE FROM FDA
SAN JOSE, CA 95112
DEVICE: EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE,
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K031946(TRADITIONAL)
ATTN: JEAN CHANG PHONE NO : 408-941-9704
1635A SOUTH MAIN STREET SE DECISION MADE: 03-NOV-03
MILPITAS, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPI-SCAN, MODEL P 100
EDX EPI-SCAN, INC. 510(k) NO: K032935(SPECIAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 20-NOV-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESG 4-WHEEL SCOOTER, ESG-03
EMG TECHNOLOGY CO., LTD. 510(k) NO: K033204(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHINU ST. SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXYCON MOBILE
ERICH JAEGER GMBH 510(k) NO: K023120(TRADITIONAL)
ATTN: EARL DRAPER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 12-NOV-03
YORBA LINDA, CA 92887-4645 510(k) STATEMENT
DEVICE: ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
EUROSURGICAL S.A. 510(k) NO: K030958(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 304-598-0525
7000 HAMPTON CENTER SE DECISION MADE: 20-NOV-03
SUITE G1 510(k) SUMMARY AVAILABLE FROM FDA
MORGANTOWN, WV 26505
DEVICE: MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
EV3 INC 510(k) NO: K033134(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 17-NOV-03
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
EV3 INC 510(k) NO: K033314(SPECIAL)
ATTN: GLEN D SMYTHE PHONE NO : 763-398-7391
4600 NATHAN LN. NORTH SE DECISION MADE: 21-NOV-03
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES
EXACTECH, INC. 510(k) NO: K032964(SPECIAL)
ATTN: GARY J MILLER PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 13-NOV-03
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CWAS 1000
FASSTECH 510(k) NO: K033452(TRADITIONAL)
ATTN: LEE BRODY PHONE NO : 978-663-2800
76 TREBLE COVE RD. SE DECISION MADE: 28-NOV-03
BUILDING #2 510(k) SUMMARY AVAILABLE FROM FDA
NORTH BILLERICA, MA 01862 THIRD PARTY REVIEW
DEVICE: FOSSA URETERAL OPEN LUMEN STENT
FOSSA MEDICAL, INC. 510(k) NO: K033368(SPECIAL)
ATTN: GLORIA KOLB PHONE NO : 617-275-7481
580 HARRISON AVE., 4TH FL. SE DECISION MADE: 26-NOV-03
BOSTON, MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERED WHEELCHAIR, MODEL FR168W
FREERIDER, CORP. 510(k) NO: K033370(TRADITIONAL)
ATTN: ROBERT S MCQUATE PHONE NO : 602-788-5651
3636 E. COLUMBINE DRIVE SE DECISION MADE: 28-NOV-03
PHOENIX, AZ 85032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
FUJIFILM MEDICAL SYSTEM U.S.A., IN 510(k) NO: K033561(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-602-3774
419 WEST AVE. SE DECISION MADE: 26-NOV-03
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC 510(k) NO: K033304(SPECIAL)
ATTN: MELISSA ROBINSON PHONE NO : 813-887-2133
8200 WEST TOWER AVE. SE DECISION MADE: 12-NOV-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEXPRO FH TELEMETRY SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC 510(k) NO: K033365(SPECIAL)
ATTN: DIANA M THORSON PHONE NO : 714-247-4135
8200 WEST TOWER AVE. SE DECISION MADE: 06-NOV-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC 510(k) NO: K033492(SPECIAL)
ATTN: LISA LEE MICHELS PHONE NO : 262-293-1609
8200 WEST TOWER AVE. SE DECISION MADE: 24-NOV-03
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSPEED 6.0 CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K033502(TRADITIONAL)
ATTN: JOHN W JAECKLE PHONE NO : 262-312-7358
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 20-NOV-03
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
GENERAL ELECTRIC CO. 510(k) NO: K033504(SPECIAL)
ATTN: LARRY A KROGER, PH.D. PHONE NO : 262-544-3894
P.O. BOX 414 SE DECISION MADE: 25-NOV-03
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
GUIDANT CORP. 510(k) NO: K033393(SPECIAL)
ATTN: KELLY PIKE PHONE NO : 408-845-3000
3200 LAKESIDE DR. SE DECISION MADE: 10-NOV-03
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS
GYRUS ENT L.L.C. 510(k) NO: K033554(TRADITIONAL)
ATTN: GREGORY SREDIN PHONE NO : 901-373-0200
2925 APPLING RD. SE DECISION MADE: 24-NOV-03
BARTLETT, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYRUS OPEN FORCEPS
GYRUS MEDICAL, INC. 510(k) NO: K024286(TRADITIONAL)
ATTN: MARK JENSEN PHONE NO : 763-416-3005
6655 WEDGWOOD ROAD, # 105 SE DECISION MADE: 17-NOV-03
MINNEAPOLIS, MN 55311-3602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODEL
HAND BIOMECHANICS LAB, INC. 510(k) NO: K033112(TRADITIONAL)
ATTN: TIMOTHY R STALLINGS PHONE NO : 916-923-5073
77 SCRIPPS DR., SUITE 104 SE DECISION MADE: 05-NOV-03
SACRAMENTO, CA 95825 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
HK SURGICAL, INC. 510(k) NO: K032802(ABBREVIATED)
ATTN: SALLY M BOWDON PHONE NO : 800-909-0060
2620A TEMPLE HEIGHTS DR. SE DECISION MADE: 19-NOV-03
OCEANSIDE, CA 92675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
HOLOGIC, INC. 510(k) NO: K033224(SPECIAL)
ATTN: DANIEL F PHELAN PHONE NO : 781-999-7300
35 CROSBY DR. SE DECISION MADE: 05-NOV-03
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
HORIZON MEDICAL PRODUCTS, INC. 510(k) NO: K033473(SPECIAL)
ATTN: SCOTT MOELLER PHONE NO : 800-472-5221
1 HORIZON WAY SE DECISION MADE: 18-NOV-03
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCORPIO NRG KNEE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K030978(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
59 ROUTE 17 SOUTH SE DECISION MADE: 20-NOV-03
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN II PELVIC CLAMP
HOWMEDICA OSTEONICS CORP. 510(k) NO: K033145(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
59 ROUTE 17 SE DECISION MADE: 05-NOV-03
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
IDEV TECHNOLOGIES, INC. 510(k) NO: K033188(TRADITIONAL)
ATTN: LYNNE A DAVIES PHONE NO : 281-333-1998
1110 NASA RD., SUITE 311 SE DECISION MADE: 19-NOV-03
HOUSTON, TX 77058-3345 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
IGC-MEDICAL ADVANCES, INC. 510(k) NO: K033292(TRADITIONAL)
ATTN: ANTHONY DIETZLER PHONE NO : 414-258-3808
10437 INNOVATION DR. SE DECISION MADE: 26-NOV-03
MILWAUKEE, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNICON CELLTRACKS ANALYZER
IMMUNICON CORP. 510(k) NO: K030263(TRADITIONAL)
ATTN: PETER SCOTT PHONE NO : 215-830-0777
3401 MASONS MILL RD. STE 100 SE DECISION MADE: 24-NOV-03
HUNTINGTON VALLEY, PA 19006-3574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG56
IMPLANT INNOVATIONS, INC. 510(k) NO: K033430(SPECIAL)
ATTN: TAMARA NELSON PHONE NO : 561-776-6923
4555 RIVERSIDE DR. SE DECISION MADE: 07-NOV-03
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-16
IMPLEX CORP. 510(k) NO: K033384(SPECIAL)
ATTN: MARCI HALEVI PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 19-NOV-03
ALLENDALE, NJ 07401-1600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPHOSOL
INPHARMA A.S. 510(k) NO: K030802(TRADITIONAL)
ATTN: BRUCE MANNING PHONE NO : 508-393-3100
96 WEST MAIN ST. SE DECISION MADE: 25-NOV-03
NORTHBOROUGH, MA 01532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERLAB IMMUNOFIXATION TEST(S)
INTERLAB S.R.L. 510(k) NO: K033187(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570-620-0198
150 CHERRY LANE RD. SE DECISION MADE: 19-NOV-03
EAST STROUDSBURG, PA 18301-8804 510(k) STATEMENT
DEVICE: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K031842(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 21-NOV-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
INTRALUMINAL THERAPEUTICS, INC. 510(k) NO: K032784(TRADITIONAL)
ATTN: PAMELA MISAJON PHONE NO : 760-918-1820
6354 CORTE DEL ABETO SE DECISION MADE: 18-NOV-03
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92009
DEVICE: COMPACT DIGITAL CARDIAC CAMERA (CDCC)
IS2 MEDICAL SYSTEMS, INC. 510(k) NO: K033199(TRADITIONAL)
ATTN: VICTOR WOODBURN PHONE NO : 613 228 8755
20 GURDWARA ROAD SE DECISION MADE: 12-NOV-03
UNITS 3-10 510(k) SUMMARY AVAILABLE FROM FDA
OTTAWA, ONTARIO, CANADA K2E 8B3
DEVICE: ENDO PAT 2000
ITAMAR MEDICAL LTD. 510(k) NO: K032519(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 977 18130
117 AHUZAH ST. SE DECISION MADE: 12-NOV-03
RA'ANANNA, ISRAEL 43373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTILINK
IVOCLAR VIVADENT, INC. 510(k) NO: K032470(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 05-NOV-03
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: JSA REPROCESSED COMPRESSION SLEEVE DEVICES
JACK SPEER AND ASSOC., INC. 510(k) NO: K031722(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 801-582-6470
1800 EAST 900 SOUTH SE DECISION MADE: 25-NOV-03
SLC, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
KEELER INSTRUMENTS, INC. 510(k) NO: K032087(TRADITIONAL)
ATTN: EUGENE VANARSDALE PHONE NO : 610-353-4350
456 PKWY. SE DECISION MADE: 26-NOV-03
BROOMALL, PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT A
KIMBERLY-CLARK CORP. 510(k) NO: K033021(TRADITIONAL)
ATTN: RICHARD V WOLFE PHONE NO : 770-587-8208
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 12-NOV-03
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VER
KINGSWELL INTERNATIONAL INC. 510(k) NO: K032670(TRADITIONAL)
ATTN: D.C. CHANG PHONE NO : 909-465-5769
264 CARBONIA AVE. SE DECISION MADE: 14-NOV-03
WALNUT, CA 91789 510(k) STATEMENT
DEVICE: KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
KONDON (TIANJIN) ELECTRONIC & ELEC 510(k) NO: K030359(TRADITIONAL)
ATTN: LIU YI PHONE NO : 86 22 27470070
NO. 31 CHANGJIANG ROAD SE DECISION MADE: 06-NOV-03
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: PANAVIA F 2.0
KURARAY MEDICAL INC. 510(k) NO: K032455(TRADITIONAL)
ATTN: SATOSHI YAMAGUCHI PHONE NO : 212-986-2230
101 EAST 52ND STREET, 26TH FL. SE DECISION MADE: 07-NOV-03
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
LABORATORIOS GRIFOLS, S.A. 510(k) NO: K031419(TRADITIONAL)
ATTN: SEBASTIAN GASCON PHONE NO : 34 935 710100
POL. LEVANTE C/CAN GUASCH, 2 SE DECISION MADE: 24-NOV-03
PARETS DEL VALLES, BARCELONA, SPAI510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STAR (LUNAR SERIES) MONITORING SYSTEM
LARSEN & TOUBRO LIMITED 510(k) NO: K032867(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 10-NOV-03
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PLANET MONITORING SYSTEM
LARSEN & TOUBRO LIMITED 510(k) NO: K032871(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
P.O. BOX 4341 SE DECISION MADE: 10-NOV-03
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AURA ISURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE 510(k) NO: K024206(TRADITIONAL)
ATTN: PAUL HARDIMAN PHONE NO : 408-943-0636
3070 ORCHARD DR. SE DECISION MADE: 17-NOV-03
SAN JOSE, CA 95134-2011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENOVA INTERNAL HEX IMPLANT SYSTEM
LIFECORE BIOMEDICAL, INC. 510(k) NO: K032774(TRADITIONAL)
ATTN: DIANE BRINZA PHONE NO : 952-368-6394
3515 LYMAN BLVD. SE DECISION MADE: 26-NOV-03
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT#
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K032764(TRADITIONAL)
ATTN: CHENG-I LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 03-NOV-03
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
LINVATEC CORP. 510(k) NO: K032607(TRADITIONAL)
ATTN: LAURA KREJCI PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 10-NOV-03
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LMT NOMAG IC 1,5
LMT LAMMERS MEDICAL TECHNOLOGY GMB 510(k) NO: K033565(ABBREVIATED)
ATTN: THOMAS M BOHNEN PHONE NO : 49 451 5809814
BESSEMERSTR. 7 SE DECISION MADE: 21-NOV-03
LUEBECK, GERMANY 23562 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BR
LONG FIRST (XIAMEN) CO.,LTD. 510(k) NO: K031170(TRADITIONAL)
ATTN: STONE CHEN PHONE NO : 886 075 612201
#23, KOOSHAN 3RD ROAD, SE DECISION MADE: 13-NOV-03
KAOHSIUNG, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
MALLINCKRODT DAR S.R.L. 510(k) NO: K031997(TRADITIONAL)
ATTN: GIUSEPPE TOMASINI PHONE NO : 011 390 535617922
VIA G.BOVE, 2/4/6/8 SE DECISION MADE: 25-NOV-03
MIRANDOLA (MODENA), ITALY 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARINA MEDICAL SILICONE PESSARY
MARINA MEDICAL INSTRUMENTS, INC. 510(k) NO: K031463(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 770-777-4146
1308 MORNINGSIDE PARK DR. SE DECISION MADE: 18-NOV-03
ALPHARETTA, GA 30022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRO FLO PERCUSSOR, MODEL 5000
MED SYSTEMS 510(k) NO: K031876(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-NOV-03
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STONE EXTRACTOR BALLOON CATHETER
MEDI-GLOBE CORP. 510(k) NO: K011261(TRADITIONAL)
ATTN: SCOTT KARLER PHONE NO : 480-897-2772
6202 SOUTH MAPLE AVE., SE DECISION MADE: 17-NOV-03
SUITE 131 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85283
DEVICE: PASSMED SPINAL SYSTEM
MEDICREA 510(k) NO: K032094(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 14-NOV-03
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICHEART, MODEL RELEASE 1
MEDICSIGHT 510(k) NO: K032823(TRADITIONAL)
ATTN: CAROL MACDONALD PHONE NO : 440 207 5985351
46 BERKELEY SQUARE SE DECISION MADE: 10-NOV-03
LONDON, UNITED KINGDOM W 1J 5AT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIC COLON MODEL, RELEASE 1
MEDICSIGHT 510(k) NO: K033102(TRADITIONAL)
ATTN: CAROL MACDONALD PHONE NO : 440 207 5985751
46 BERKELEY SQUARE SE DECISION MADE: 05-NOV-03
LONDON, UNITED KINGDOM W 1J 5AT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE MONITOR, MODEL M100
MEDITEK TECHNOLOGY, INC. 510(k) NO: K032308(TRADITIONAL)
ATTN: TONY C.S. CHANG PHONE NO : 886 4 22972787
NO. 5, ALLEY 5, LN CHENG HSING SE DECISION MADE: 10-NOV-03
CHUNG CHING RD. 510(k) SUMMARY AVAILABLE FROM FDA
PEI TUN DIST., TAICHUNG, CHINA (TAIWAN)
DEVICE: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
MEDRAD, INC. 510(k) NO: K033247(SPECIAL)
ATTN: TROY A JACK PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 05-NOV-03
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE -ER
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K033334(SPECIAL)
ATTN: ALAN MORRIS PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 10-NOV-03
BURLINGTON, NC 27215 510(k) STATEMENT
DEVICE: SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SE
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K033416(SPECIAL)
ATTN: RONALD W BENNETT PHONE NO : 763-391-9086
7611 NORTHLAND DR. SE DECISION MADE: 05-NOV-03
BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K033468(SPECIAL)
ATTN: MICHELE PYFFEROEN PHONE NO : 763-391-9136
7611 NORTHLAND DR. SE DECISION MADE: 14-NOV-03
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEPAK 12, 20, 500, CR PLUS
MEDTRONIC PHYSIO-CONTROL CORP. 510(k) NO: K033275(SPECIAL)
ATTN: MICHELLE ACKERMANN PHONE NO : 425-867-4744
11811 WILLOWS RD NE SE DECISION MADE: 06-NOV-03
P.O. BOX 97006 510(k) SUMMARY AVAILABLE FROM FDA
REDMOND, WA 98073-9706
DEVICE: DYNALOK CLASSIC SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K033271(SPECIAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 06-NOV-03
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA VANCOMYCIN ASSAY
MICROGENICS CORP. 510(k) NO: K032811(TRADITIONAL)
ATTN: DAVID CASAL PHONE NO : 510-979-5012
46360 FREMONT BLVD. SE DECISION MADE: 24-NOV-03
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
MICROLIFE CORP. 510(k) NO: K031024(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 14-NOV-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2
MICRON CORP. 510(k) NO: K032995(SPECIAL)
ATTN: TAKASHI TERUI PHONE NO : 81 3 37260396
1-34-14 HIGASHIYUKIGAYA SE DECISION MADE: 20-NOV-03
OTA-KU, TOKYO, JAPAN 145-0065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLIBRI DISPOSABLE VITRECTOMY CUTTER
MICROWORLD MEDICAL INSTRUMENTS, IN 510(k) NO: K033390(TRADITIONAL)
ATTN: SEMYON GAMBARIN PHONE NO : 510-534-7401
4640 MALAT ST. SE DECISION MADE: 04-NOV-03
OAKLAND, CA 94601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MICRUS MICROCOIL SYSTEM
MICRUS CORP. 510(k) NO: K032872(TRADITIONAL)
ATTN: MARGARET WEBBER PHONE NO : 408-830-5900
610 PALOMAR AVENUE SE DECISION MADE: 28-NOV-03
MOUNTAIN VIEW, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
MIELE, INC. 510(k) NO: K031799(SPECIAL)
ATTN: STEVE POLINSKI PHONE NO : 609-419-9898
9 INDEPENDENCE WAY SE DECISION MADE: 12-NOV-03
PRINCETON, NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARADIGMPAL, MODEL MMT-7330
MINIMED, INC. 510(k) NO: K031541(TRADITIONAL)
ATTN: GERDA P RESCH PHONE NO : 818-362-5958
18000 DEVONSHIRE ST. SE DECISION MADE: 18-NOV-03
NORTHRIDGE, CA 91325 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRAGEL CSF ISOFOCUSING KITS
MORAX 510(k) NO: K033277(SPECIAL)
ATTN: BOREK JANIK PHONE NO : 734-475-2441
SUITE 400 SE DECISION MADE: 04-NOV-03
1705 CORPORATE DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30093
DEVICE: MPS ACACIA SAFEGUARD HUBER DEVICE
MPS ACACIA 510(k) NO: K032934(TRADITIONAL)
ATTN: FERGIE F FERGUSON PHONE NO : 714-257-0470
499 NIBUS ST., SUITE E SE DECISION MADE: 13-NOV-03
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
MRI DEVICES CORP. 510(k) NO: K033567(SPECIAL)
ATTN: THOMAS SCHUBERT PHONE NO : 262-524-1402
1515 PARAMOUNT DR. SE DECISION MADE: 25-NOV-03
WAUKESHA, WI 53186 510(k) STATEMENT
DEVICE: ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660
MULTINATIONAL 510(k) NO: K031820(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 12-NOV-03
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHILEY FLEXTRA TRACHEOSTOMY TUBE
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K030787(TRADITIONAL)
ATTN: GINA TO PHONE NO : 925-463-4427
4280 HACIENDA DR. SE DECISION MADE: 14-NOV-03
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTIVA SB GUIDEWIRE
NEO METRICS, INC. 510(k) NO: K033321(SPECIAL)
ATTN: MARK PEDERSON PHONE NO : 763-559-4440
14800 28TH AVENUE NORTH SE DECISION MADE: 05-NOV-03
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: MODIFICATION TO EN-BLOC BIOPSY SYSTEM
NEOTHERMIA CORP. 510(k) NO: K033427(SPECIAL)
ATTN: SHERRIE COVAL-GOLDSMITH PHONE NO : 508-655-7820
ONE APPLE HILL SE DECISION MADE: 10-NOV-03
SUITE 316 510(k) SUMMARY AVAILABLE FROM FDA
NATICK, MA 01760
DEVICE: MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
NIPRO MEDICAL CORP. 510(k) NO: K032777(SPECIAL)
ATTN: RICHARD D BLISS PHONE NO : 954-385-1690
510 STONEMONT DR. SE DECISION MADE: 14-NOV-03
WESTON, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE
NOVABONE PRODUCTS, LLC 510(k) NO: K031073(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
ONE PROGRESS BLVD. SE DECISION MADE: 05-NOV-03
SUITE 33 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615
DEVICE: GE PRECISION MPI
NRT-NORDISK RONTGEN TEKNIK A/S 510(k) NO: K033486(TRADITIONAL)
ATTN: JAN MALLING PHONE NO : 458 628 3500
BIRKEGAARDSVEJ 16 SE DECISION MADE: 19-NOV-03
HASSELAGER, DENMARK 8361 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NUVASIVE MESH
NUVASIVE, INC. 510(k) NO: K032476(SPECIAL)
ATTN: LAETITIA BERNARD PHONE NO : 858-229-9924
10065 OLD GROVE RD. SE DECISION MADE: 13-NOV-03
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE PUREFLOW SOLUTION
NXSTAGE MEDICAL, INC. 510(k) NO: K033386(SPECIAL)
ATTN: NORMA LEMAY PHONE NO : 978-687-4700
439 SOUTH UNION ST. SE DECISION MADE: 26-NOV-03
SUITE 501 510(k) SUMMARY AVAILABLE FROM FDA
LAWRENCE, MA 01843
DEVICE: ACCUMAP AUTOMATIC PERIMETER
OBJECTIVISION PTY LTD. 510(k) NO: K022304(TRADITIONAL)
ATTN: FRED HENRY PHONE NO : 484-679-2400
185 JORDAN RD. SE DECISION MADE: 14-NOV-03
TROY, NY 12180 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C C
OLYMPUS AMERICA, INC. 510(k) NO: K031380(TRADITIONAL)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 14-NOV-03
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
OLYMPUS AMERICA, INC. 510(k) NO: K032665(ABBREVIATED)
ATTN: MICHAEL CAMPBELL PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 21-NOV-03
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRA
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K033300(TRADITIONAL)
ATTN: CHARLOTTE BAKER PHONE NO : 585-453-3730
100 INDIGO CREEK DR. SE DECISION MADE: 05-NOV-03
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITOSS-FILLED CARTRIDGE
ORTHOVITA, INC. 510(k) NO: K032130(SPECIAL)
ATTN: ANDREINA ANGIE IDE PHONE NO : 610-407-5231
45 GREAT VALLEY PKWY. SE DECISION MADE: 05-NOV-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
OSTEOMED L.P. 510(k) NO: K031708(TRADITIONAL)
ATTN: DAWN T HOLDERMAN PHONE NO : 972-677-4600
3885 ARAPAHO RD. SE DECISION MADE: 03-NOV-03
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCO MIC AND MIC/ID PANELS
PASCO LABORATORIES, INC. 510(k) NO: K033119(TRADITIONAL)
ATTN: LINDA E DILLON PHONE NO : 303-390-3240
12750 WEST 42ND AVE. SE DECISION MADE: 18-NOV-03
WHEAT RIDGE, CO 80033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE TOLERANCE BEVERAGE
PERK SCIENTIFIC, INC. 510(k) NO: K032753(TRADITIONAL)
ATTN: MARK BARTOSH PHONE NO : 610-259-1009
520 COMMERCE DR. SE DECISION MADE: 18-NOV-03
YEADON, PA 19050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
PETER M. ROTHENBERG, M.D. 510(k) NO: K032613(TRADITIONAL)
ATTN: PETER M ROTHENBERG PHONE NO : 949-489-9039
657 CAMINO DE LOS MARES SE DECISION MADE: 20-NOV-03
SUITE 137 510(k) SUMMARY AVAILABLE FROM FDA
SAN CLEMENTE, CA 92673
DEVICE: PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MU
PHILIPS MEDICAL SYSTEMS 510(k) NO: K033444(SPECIAL)
ATTN: TAPAN D SHAH PHONE NO : 978-659-7681
3000 MINUTEMAN RD. SE DECISION MADE: 21-NOV-03
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) A
PLAYTEX PRODUCTS, INC. 510(k) NO: K032636(TRADITIONAL)
ATTN: KAREN A COSTA PHONE NO : 201-785-8090
75 COMMERCE DR. SE DECISION MADE: 14-NOV-03
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERI
PORTEX LTD. 510(k) NO: 510(k) NO: K032716(TRADITIONAL)
ATTN: STEVE OGILVIE PHONE NO : 00 440 1303260551
MILITARY ROAD SE DECISION MADE: 28-NOV-03
HYTHE, KENT, UNITED KINGDOM CT 21 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCHECK WEAK LUPUS POSITIVE CONTROL
PRECISION BIOLOGIC 510(k) NO: K032804(TRADITIONAL)
ATTN: STEPHEN DUFF PHONE NO : 902 468 6422
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 03-NOV-03
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON
PRO-MED INSTRUMENTS GMBH 510(k) NO: K032331(TRADITIONAL)
ATTN: JIM BAZZINOTTI PHONE NO : 239-225-4086
1899 SAWYER LANE SE DECISION MADE: 20-NOV-03
ALVA, FL 33920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARAMIS II DERMATOLOGICAL LASER
QUANTEL MEDICAL 510(k) NO: K032260(TRADITIONAL)
ATTN: ROGER W BARNES PHONE NO : 501-525-8612
342 SUNSET BAY RD. SE DECISION MADE: 20-NOV-03
HOT SPRINGS, AR 71913 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUASAR, MODEL MD21
QUANTUM SKINCARE, INC. 510(k) NO: K032379(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 832-285-9423
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 20-NOV-03
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANT LASER SYSTEM
RELIANT TECHNOLOGIES, INC. 510(k) NO: K031795(TRADITIONAL)
ATTN: HEATHER TANNER PHONE NO : 650-473-0200
260 SHERIDAN AVE. SE DECISION MADE: 10-NOV-03
PALO ALTO, CA 94306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
REMEL INC 510(k) NO: K031834(TRADITIONAL)
ATTN: EARLEEN C PARKS PHONE NO : 913-895-4185
12076 SANTA FE DRIVE SE DECISION MADE: 10-NOV-03
LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
REMEL INC 510(k) NO: K031942(TRADITIONAL)
ATTN: RICHARD TYSON PHONE NO : 763-712-2347
1400 UNITY ST. NORTHWEST SE DECISION MADE: 18-NOV-03
RAMSEY, MN 55303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
REMEL INC 510(k) NO: K031965(TRADITIONAL)
ATTN: RICHARD TYSON PHONE NO : 763-712-2347
1400 UNITY ST. NORTHWEST SE DECISION MADE: 14-NOV-03
RAMSEY, MN 55303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
RENU MEDICAL, INC. 510(k) NO: K031559(TRADITIONAL)
ATTN: L. BRUCE PIERSON PHONE NO : 425-353-1110
9800 EVERGREEN WAY SE DECISION MADE: 12-NOV-03
EVERETT, WA 98204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLV CONTINUUM VENTILATOR, MODEL P1000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K022750(TRADITIONAL)
ATTN: MARY FUNK PHONE NO : 760-918-7300
2271 COSMOS CT. SE DECISION MADE: 20-NOV-03
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOSPITAL SPACER
RESPIRONICS HEALTHSCAN, INC. 510(k) NO: K032809(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SE DECISION MADE: 13-NOV-03
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
REVIVANT CORP. 510(k) NO: K032852(SPECIAL)
ATTN: BOB H KATZ PHONE NO : 408-524-3500
775 PALOMAR AVE. SE DECISION MADE: 12-NOV-03
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PROBNP IMMUNOASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K032646(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 12-NOV-03
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033501(SPECIAL)
ATTN: SHERRI L COENEN PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 20-NOV-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
ROCHE DIAGNOSTICS CORP. 510(k) NO: K033548(SPECIAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-3742
9115 HAGUE RD. SE DECISION MADE: 24-NOV-03
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO-BAND LIGATOR
SCANDIMED. A.S. 510(k) NO: K031236(TRADITIONAL)
ATTN: KRISTIAN K JENSEN PHONE NO : 454 492 6444
SLOTSHERRENSVEJ 409 SE DECISION MADE: 14-NOV-03
GLOSTROP, DENMARK DK 2600 510(k) STATEMENT
DEVICE: PROFILE BBL SYSTEM
SCITON, INC. 510(k) NO: K032460(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
845 COMMERCIAL ST. SE DECISION MADE: 13-NOV-03
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCR SPINAL SYSTEM
SEASPINE 510(k) NO: K032739(SPECIAL)
ATTN: DIANA SMITH PHONE NO : 619-251-9132
727 PARK BLVD. SE DECISION MADE: 20-NOV-03
SAN DIEGO, CA 92101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASTALGIN AND PLASTALGIN ORTHO
SEPTODONT 510(k) NO: K032708(TRADITIONAL)
ATTN: WAYNE H MATELSKI, ESQ. PHONE NO : 202-857-6340
1050 CONNECTICUT AVE., NW SE DECISION MADE: 20-NOV-03
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SUR
SGMP CO., LTD. 510(k) NO: K023537(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 20-NOV-03
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
SHEN WEI (USA), INC. 510(k) NO: K030583(TRADITIONAL)
ATTN: BELLE L CHOU PHONE NO : 510-429-8692
2845 WHIPPLE RD. SE DECISION MADE: 10-NOV-03
UNION CITY, CA 94587 510(k) STATEMENT
DEVICE: FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG FUGUAN PLASTIC PRODUC 510(k) NO: K032907(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 666660125
RM. 707, AVIC BLDG., NO.2 SE DECISION MADE: 20-NOV-03
DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT; BEIJING, CHINA 100022
DEVICE: FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
SHIJIAZHUANG FUGUAN PLASTIC PRODUC 510(k) NO: K032908(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 666660125
RM. 707, AVIC BLDG., NO.2 SE DECISION MADE: 20-NOV-03
DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT; BEIJING, CHINA 100022
DEVICE: LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K033374(SPECIAL)
ATTN: RUDIGER KORNER PHONE NO : 499 191 189355
SIEMENSSTRASSE 1 SE DECISION MADE: 06-NOV-03
FORCHHEIM, GERMANY D 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND S
SIEMENS MEDICAL SOLUTIONS USA, INC 510(k) NO: K031340(TRADITIONAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 25-NOV-03
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
SIEMENS MEDICAL SOLUTIONS USA, INC 510(k) NO: K032475(ABBREVIATED)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PKWY. SE DECISION MADE: 10-NOV-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
SIEMENS MEDICAL SOLUTIONS USA, INC 510(k) NO: K032536(ABBREVIATED)
ATTN: NEALIE K HARTMAN PHONE NO : 610-481-1769
51 VALLEY STREAM PKWY. SE DECISION MADE: 10-NOV-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
SIEMENS MEDICAL SOLUTIONS USA, INC 510(k) NO: K033335(SPECIAL)
ATTN: DEBBIE PEACOCK PHONE NO : 610-448-1773
51 VALLEY STREAM PKWY. SE DECISION MADE: 25-NOV-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILETTE XP AND MOBILETT XPHYBRID
SIEMENS MEDICAL SYSTEMS, INC. 510(k) NO: K033238(SPECIAL)
ATTN: NEALIE HARTMAN PHONE NO : 610-448-1769
51 VALLEY STREAM PARKWAY SE DECISION MADE: 14-NOV-03
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAINBOW GT-4A PAIN RELIEF MACHINE
SINO-US INFORMATION, INC 510(k) NO: K031546(TRADITIONAL)
ATTN: YITANG SHENG PHONE NO : 718-846-6868
85-13 88TH AVE. SE DECISION MADE: 13-NOV-03
WOODHAVEN, NY 11421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K032543(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 14-NOV-03
NORTH ATTLEBORO, MA 02760-4153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLECTION CONSTRAINED LINER
SMITH & NEPHEW, INC. 510(k) NO: K033442(SPECIAL)
ATTN: KANU VADODARIA PHONE NO : 901-399-6261
1450 E. BROOKS RD. SE DECISION MADE: 26-NOV-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERSABOND BONE CEMENT
SMITH & NEPHEW, INC. 510(k) NO: K033509(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-5153
1450 E. BROOKS RD. SE DECISION MADE: 28-NOV-03
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASCAL DYNAMIC CONTOUR TONOMETER
SMT SWISS MICROTECHNOLOGY AG 510(k) NO: K032967(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 14-NOV-03
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 18
SONOSITE,INC. 510(k) NO: K033367(TRADITIONAL)
ATTN: MICHAEL A HOFFMAN PHONE NO : 425-951-1297
21919 30TH DRIVE SE. SE DECISION MADE: 05-NOV-03
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
SORENSON MEDICAL, INC. 510(k) NO: K033325(SPECIAL)
ATTN: DOUGLAS BUESCHEL PHONE NO : 801-352-6267
1375 WEST 8040 SOUTH SE DECISION MADE: 06-NOV-03
WEST JORDAN, UT 84088-8320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
SORENSON MEDICAL, INC. 510(k) NO: K033425(SPECIAL)
ATTN: DOUGLAS BUESCHEL PHONE NO : 801-352-6267
1375 WEST 8040 SOUTH SE DECISION MADE: 06-NOV-03
WEST JORDAN, UT 84088-8320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROLASE, MODELS 150V, 150C, 1064
SPECTRUM LASER & TECHNOLOGIES 510(k) NO: K032787(TRADITIONAL)
ATTN: THOMAS R RADEBAUGH PHONE NO : 719-264-7632
4980 A CENTENNIAL BLVD. SE DECISION MADE: 20-NOV-03
COLORADO SPRINGS, CO 80919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOOD MORNING TEST
STANDARD DIAGNOSTICS, INC. 510(k) NO: K031798(TRADITIONAL)
ATTN: RICHARD C LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 12-NOV-03
SOUND BEACH, NY 11789-1734 510(k) STATEMENT
DEVICE: STELKAST UNICONDYLAR KNEE SYSTEM
STELKAST COMPANY 510(k) NO: K032824(TRADITIONAL)
ATTN: DONALD STEVENS PHONE NO : 724-941-6368
200 HIDDEN VALLEY ROAD SE DECISION MADE: 13-NOV-03
MCMURRAY, PA 15317 510(k) STATEMENT
DEVICE: MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
STRYKER ENDOSCOPY 510(k) NO: K033252(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 408-754-2148
5900 OPTICAL CT. SE DECISION MADE: 13-NOV-03
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
STRYKER INSTRUMENTS 510(k) NO: K032473(TRADITIONAL)
ATTN: ROBIN L ROWE PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 07-NOV-03
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUMMIT STAIRWAY LIFT
SUMMIT LIFTS, INC. 510(k) NO: K032880(ABBREVIATED)
ATTN: KENT PERRY PHONE NO : 913-498-1700
7300 W. 110TH STREET SE DECISION MADE: 10-NOV-03
SUITE 260 510(k) SUMMARY AVAILABLE FROM FDA
OVERLAND PARK, KS 66210
DEVICE: CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
SURGITECH, INC. 510(k) NO: K033358(TRADITIONAL)
ATTN: CHRISTOPHER CROWELL PHONE NO : 760-450-0194
2424 VISTA WAY, SUITE 300 SE DECISION MADE: 14-NOV-03
OCEANSIDE, CA 92054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMISE
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K032921(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 W. COLLINS AVE. SE DECISION MADE: 13-NOV-03
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
SYNERGETICS, INC. 510(k) NO: K032598(TRADITIONAL)
ATTN: DAN REGAN PHONE NO : 636-939-5100
3845 CORPORATE CENTRE DR. SE DECISION MADE: 24-NOV-03
ST. CHARLES, MO 63304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLICK'X MONOAXIAL SCREWS AND HOOKS
SYNTHES (USA) 510(k) NO: K031175(TRADITIONAL)
ATTN: JOHN WALSH PHONE NO : 484-356-9621
1690 RUSSELL RD. SE DECISION MADE: 14-NOV-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
SYNTHES (USA) 510(k) NO: K033071(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 05-NOV-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
SYNTHES (USA) 510(k) NO: K033158(TRADITIONAL)
ATTN: ANGLELA J SILVESTRI PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 05-NOV-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WI
SYNTHES (USA) 510(k) NO: K033411(SPECIAL)
ATTN: BONNIE SMITH PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 26-NOV-03
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
TAIWAN KING STRONG CO., LTD. 510(k) NO: K033097(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) STATEMENT
DEVICE: GIARDIA II
TECHLAB, INC. 510(k) NO: K033274(SPECIAL)
ATTN: DAVID M LYERLY PHONE NO : 540-953-1664
1861 PRATT DR., STE. 1030 SE DECISION MADE: 04-NOV-03
BLACKSBURG, VA 24060-6364 510(k) STATEMENT
DEVICE: ORTRAUTEK TRAUMA SYSTEM
TEKKA 510(k) NO: K032520(TRADITIONAL)
ATTN: FAYYAZ MEMON PHONE NO : 301-263-0544
6512 BANNOCKBURN DRIVE SE DECISION MADE: 12-NOV-03
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIHA +
TEKNIMED SA 510(k) NO: K031826(TRADITIONAL)
ATTN: J. D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 28-NOV-03
ROUNDROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEMSTOP CEMENT RESTRICTOR
TEKNIMED SA 510(k) NO: K032685(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 26-NOV-03
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHODEK
TELEFLEX MEDICAL 510(k) NO: K033115(TRADITIONAL)
ATTN: STEPHEN PAGE PHONE NO : 508-677-6600
600 AIRPORT RD. SE DECISION MADE: 17-NOV-03
FALL RIVER, MA 02720-4740 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHM DIGITAL ELECTRONIC STETHOSCOPE
THINKLABS INC. 510(k) NO: K032230(TRADITIONAL)
ATTN: RICHARD LANZILLOTTO PHONE NO : 631-744-0059
30 NORTHPORT ROAD SE DECISION MADE: 26-NOV-03
SOUND BEACH, NY 11789 510(k) STATEMENT
DEVICE: SPI EASY DENTAL IMPLANT PROTECTIVE CAP
THOMMEN MEDICAL, AG 510(k) NO: K033346(SPECIAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON RD. SE DECISION MADE: 03-NOV-03
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TLC MODELS ULK-H AND ULT-H INFRARED LAMPS
TLC MARKETING, INC. 510(k) NO: K033035(TRADITIONAL)
ATTN: ROBERT MAZZAFERRO PHONE NO : 301-216-2720
11 DELLCASTLE COURT SE DECISION MADE: 20-NOV-03
MONTGOMERY VILLAGE, MD 20886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: HI-ART SYSTEM
TOMOTHERAPY INCORPORATED 510(k) NO: K033347(SPECIAL)
ATTN: KENNETH D BUROKER PHONE NO : 608-824-2811
1240 DEMING WAY SE DECISION MADE: 12-NOV-03
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
TOSHIBA AMERICA MEDICAL SYSTEMS, I 510(k) NO: K033418(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 10-NOV-03
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: LEGIONELLA PNEUMOPHILA IGG/IGM
TRINITY BIOTECH USA 510(k) NO: K033051(TRADITIONAL)
ATTN: BONNIE DEJOY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYCOPLASMA IGG
TRINITY BIOTECH USA 510(k) NO: K033064(TRADITIONAL)
ATTN: BONNIE B DEJOY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYLORI IGG
TRINITY BIOTECH USA 510(k) NO: K033067(TRADITIONAL)
ATTN: BONNIE B DEJOY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
TRINITY BIOTECH USA 510(k) NO: K033070(TRADITIONAL)
ATTN: BONNIE B DEJOY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHLAMYDIA IGG ELISA TEST SYSTEM
TRINITY BIOTECH USA 510(k) NO: K033079(TRADITIONAL)
ATTN: BONNIE B DEJOY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
TRINITY BIOTECH USA 510(k) NO: K033083(TRADITIONAL)
ATTN: BONNIE B DEJOY PHONE NO : 716-483-3851
P.O. BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702-1059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERPES GROUP IGG
TRINITY BIOTECH, INC. 510(k) NO: K033059(TRADITIONAL)
ATTN: BONNIE DEJOY PHONE NO : 716-483-3851
PO BOX 1059 SE DECISION MADE: 26-NOV-03
JAMESTOWN, NY 14702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033219(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033239(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320
TUNG KENG ENTERPRISE CO., LTD. 510(k) NO: K033241(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58 FU-CHIUN ST. SE DECISION MADE: 10-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 427 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOJECT INSULIN SYRINGE
TYCO HEALTHCARE 510(k) NO: K033373(SPECIAL)
ATTN: DAVID OLSON PHONE NO : 508-261-8530
15 HAMPSHIRE ST. SE DECISION MADE: 13-NOV-03
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRADENT CITRIC ACID 10% SOLUTION
ULTRADENT PRODUCTS, INC. 510(k) NO: K032627(TRADITIONAL)
ATTN: PETER ALLRED PHONE NO : 800-552-5512
505 WEST 10200 SOUTH SE DECISION MADE: 12-NOV-03
SOUTH JORDAN, UT 84095 510(k) STATEMENT
DEVICE: CAPROSYN ABSORBABLE SUTURE
UNITED STATES SURGICAL, A DIVISION 510(k) NO: K032586(ABBREVIATED)
ATTN: ROBERT ZOTT PHONE NO : 203-845-4515
150 GLOVER AVE. SE DECISION MADE: 17-NOV-03
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GROWTH GUIDANCE PLATE
UNIVERSITY OF UTAH/SCHOOL OF MEDIC 510(k) NO: K031493(TRADITIONAL)
ATTN: PETER M STEVENS PHONE NO : 801-588-3900
P.O. BOX #58246 SE DECISION MADE: 20-NOV-03
SALT LAKE CITY, UT 84158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG
UNOTECH DIAGNOSTICS, INC. 510(k) NO: K032987(TRADITIONAL)
ATTN: KEN WU PHONE NO : 510-352-3070
2235 POLVOROSA AVE., SUITE 220 SE DECISION MADE: 17-NOV-03
SAN LEANDRO, CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY
USA INSTRUMENTS, INC. 510(k) NO: K033353(SPECIAL)
ATTN: CHRISTIE SHUMAKER PHONE NO : 330-995-8572
1515 DANNER DR. SE DECISION MADE: 14-NOV-03
AURORA, OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALIS IRRIGATION MODULE 1000
VALLEY FORGE SCIENTIFIC CORP. 510(k) NO: K033499(SPECIAL)
ATTN: JERRY L MALIS PHONE NO : 610-666-7500
136 GREEN TREE RD., STE. 100 SE DECISION MADE: 28-NOV-03
PO BOX 1179 510(k) SUMMARY AVAILABLE FROM FDA
OAKS, PA 19456
DEVICE: GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K031524(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 26-NOV-03
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
VASCULAR SOLUTIONS, INC. 510(k) NO: K033237(TRADITIONAL)
ATTN: DEBORAH L JENSEN PHONE NO : 763-656-4349
6464 SYCAMORE COURT SE DECISION MADE: 20-NOV-03
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIROPRO SPO2
VIASYS HEALTHCARE GMBH 510(k) NO: K031515(TRADITIONAL)
ATTN: EARL DRAPER PHONE NO : 714-283-2228
22705 SAVI RANCH PKWY. SE DECISION MADE: 14-NOV-03
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRONIX V3D VASCULAR, REVISION 1.0
VIATRONIX, INC. 510(k) NO: K033361(TRADITIONAL)
ATTN: FRANK DACHILLE PHONE NO : 631-444-6759
25 EAST LOOP RD., SUITE 204 SE DECISION MADE: 05-NOV-03
STONY BROOK, NY 11790 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VITERION 100 TELEHEALTH MONITOR
VITERION TELEHEALTHCARE LLC 510(k) NO: K030419(TRADITIONAL)
ATTN: SEAN M CURRY PHONE NO : 858-675-8200
16787 BERNARDO CENTER DR. SE DECISION MADE: 06-NOV-03
SUITE A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128-2504
DEVICE: GRANDIO FLOW
VOCO GMBH 510(k) NO: K033117(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 25-NOV-03
BEND, OR 97702 510(k) STATEMENT
DEVICE: GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K032865(TRADITIONAL)
ATTN: MIKE JOHNSON PHONE NO : 928-864-3615
3450 WEST KILTIE LN. SE DECISION MADE: 28-NOV-03
FLAGSTAFF, AZ 86002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BESTALOY
WE DONG MYUNG DENTAL INDUSTRIAL CO 510(k) NO: K033434(TRADITIONAL)
ATTN: RONALD D ARKIN PHONE NO : 770-565-6166
1733 CANTON LN. SE DECISION MADE: 12-NOV-03
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: E-SARANG 86, DM78, DM55
WE DONG MYUNG DENTAL INDUSTRIAL CO 510(k) NO: K033435(TRADITIONAL)
ATTN: RONALD D ARKIN PHONE NO : 770-565-6166
1733 CANTON LN. SE DECISION MADE: 12-NOV-03
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG
WE DONG MYUNG DENTAL INDUSTRIAL CO 510(k) NO: K033446(TRADITIONAL)
ATTN: RONALD D ARKIN PHONE NO : 770-565-6166
1733 CANTON LN. SE DECISION MADE: 13-NOV-03
MARIETTA, GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K030319(ABBREVIATED)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 26-NOV-03
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOI
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K032647(TRADITIONAL)
ATTN: TERENCE LIM PHONE NO : 60 03 87061486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 07-NOV-03
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: WU'S 4-WHEELED SCOOTER, WT-L4JR
WU'S TECH CO., LTD. 510(k) NO: K032617(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-03
NSIN-CHU CITY, ROC, CHINA (TAIWAN)510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
WU'S TECH CO., LTD. 510(k) NO: K033032(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 10-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) ROC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
XITEC HOLDINGS LLC. 510(k) NO: K033066(SPECIAL)
ATTN: DANIEL J DILLON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 12-NOV-03
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y.E.S POWERED WHEELCHAIR. T180
YEOU EIR SHUEN MACHINERY CO., LTD. 510(k) NO: K032512(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, ROC, CHINA (TAIWAN)510(k) STATEMENT
DEVICE: Y.E.S. POWERED WHEELCHAIR, MODEL T200
YEOU EIR SHUEN MACHINERY CO., LTD. 510(k) NO: K032669(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 12-NOV-03
HSIN-CHU CITY, CHINA (TAIWAN) 510(k) STATEMENT
DEVICE: BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO BLUE SAIL PLASTIC & RUBBER PR 510(k) NO: K032781(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 86 106 5666660125
RM 707, AVIC BLDG., NO. 2 SE DECISION MADE: 13-NOV-03
DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT, BEIJING, CHINA 100022
DEVICE: BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
ZIBO BLUE SAIL PLASTIC & RUBBER PR 510(k) NO: K032783(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 86 106 5666660125
RM 707, AVIC BLDG., NO. 2 SE DECISION MADE: 13-NOV-03
DONG SAN HUAN NAN ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT, BEIJING, CHINA 100022
DEVICE: VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
ZIMMER, INC. 510(k) NO: K033034(SPECIAL)
ATTN: KAREN CAIN PHONE NO : 574-372-4219
P.O. BOX 708 SE DECISION MADE: 05-NOV-03
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHA
ZOLL MEDICAL CORP. 510(k) NO: K032439(ABBREVIATED)
ATTN: SCOTT AUGUST PHONE NO : 800-348-9011
269 MILL ROAD SE DECISION MADE: 05-NOV-03
CHELMSFORD, MA 01824-4105 510(k) STATEMENT
DEVICE: ZOLL AUTOCLAVABLE INTERNAL HANDLES
ZOLL MEDICAL CORP. 510(k) NO: K032691(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 978-421-9655
269 MILL ROAD SE DECISION MADE: 13-NOV-03
CHELMSFORD, MA 01824-4105 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 271
TOTAL WITH SUMMARIES 236
TOTAL WITH STATEMENTS 35
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