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510(k)s Final Decisions Rendered for November 2003 |
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, INC510(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 PROSTHETIC510(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., IN510(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 TEC510(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 TEC510(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 TEC510(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 & ELEC510(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 GMB510(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, IN510(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: 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 PRODUC510(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 PRODUC510(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, INC510(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, INC510(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, INC510(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, INC510(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, I510(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 DIVISION510(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 MEDIC510(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 CO510(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 CO510(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 CO510(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 PR510(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 PR510(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
Updated December 8, 2003
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