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510(k)s Final Decisions Rendered for January 2005 |
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SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JAN-2005 THROUGH 31-JAN-2005
DEVICE: CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM
CYNOSURE, INC. 510(k) NO: K030876(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DRIVE SE DECISION MADE: 22-JAN-05
CHELMSFORD, MA 01824-4145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HERMES BOND 2
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K043043(TRADITIONAL)
ATTN: ANDREAS PETERMANN PHONE NO : 011 498 1527001395
ESPE PLATZ SE DECISION MADE: 10-JAN-05
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWERSTICK MALE LATEX CONDOMS
A.P.DEAUVILLE, LLC. 510(k) NO: K041717(ABBREVIATED)
ATTN: SCOTT L BAIER PHONE NO : 732-545-0200
594 JERSEY AVE. SE DECISION MADE: 13-JAN-05
NEW BRUNSWICK, NJ 08901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY VR RADIOPAQUE BONE CEMENT, MODELS CM-VR-1040, CM-VR-102
ADVANCED BIOMATERIAL SYSTEMS, INC.510(k) NO: K042168(TRADITIONAL)
ATTN: MARIE MARLOW PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 14-JAN-05
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
AIZU OLYMPUS CO., LTD. 510(k) NO: K043487(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 631-844-5688
TWO CORPORATE CENTER DRIVE SE DECISION MADE: 28-JAN-05
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
AMPLIFE CORPORATION 510(k) NO: K043550(TRADITIONAL)
ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 27-JAN-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL
ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K043508(TRADITIONAL)
ATTN: LON D MCILVAIN PHONE NO : 334-615-2562
1635 INDUSTRIAL ROAD SE DECISION MADE: 19-JAN-05
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSURG TROCAR
AOMORI OLYMPUS CO., LTD. 510(k) NO: K042160(TRADITIONAL)
ATTN: TINA STEFFANIE-OAK PHONE NO : 631-844-5477
2 CORPORATE CENTER DR. SE DECISION MADE: 25-JAN-05
MELVILLE, NY 11747-3157 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYTOVISION FOR CEP XY
APPLIED IMAGING CORP. 510(k) NO: K042542(TRADITIONAL)
ATTN: DIANE C DAY PHONE NO : 408-719-6400
120 BAYTECH DRIVE SE DECISION MADE: 10-JAN-05
SAN JOSE, CA 95134-2302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTAL RADIO-ULNAR JOINT IMPLANT
APTIS MEDICAL, LLC. 510(k) NO: K040497(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-922-3974
P.O. BOX 249 SE DECISION MADE: 26-JAN-05
DEL MAR, CA 92014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
ASAHI INTECC CO., LTD. 510(k) NO: K043422(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET SE DECISION MADE: 12-JAN-05
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT BEACH, CA 92660
DEVICE: ATAD ARD CATHETER
ATAD DEVELOPMENTS LTD. 510(k) NO: K040625(TRADITIONAL)
ATTN: JACK ATAD PHONE NO : 972 482 43342
70 YAKINTON ST. SE DECISION MADE: 18-JAN-05
RAMAT ALMOGI 510(k) SUMMARY AVAILABLE FROM FDA
HAIFA, ISRAEL 34792
DEVICE: OCEAN CHEST DRAIN
ATRIUM MEDICAL CORP. 510(k) NO: K043582(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 21-JAN-05
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: PROCEDUR 10 SYRINGE DEVICE
AVANCA MEDICAL DEVICES, INC. 510(k) NO: K042486(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 21-JAN-05
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: PROCEDUR SF SAFETY SYRINGE DEVICE
AVANCA MEDICAL DEVICES, INC. 510(k) NO: K042487(TRADITIONAL)
ATTN: FRANK FERGUSON PHONE NO : 505-332-8445
12200 ACADEMY ROAD NE SE DECISION MADE: 21-JAN-05
# 931 510(k) SUMMARY AVAILABLE FROM FDA
ALBUQUERQUE, NM 87111
DEVICE: ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
B-K MEDICAL A/S 510(k) NO: K043524(SPECIAL)
ATTN: VILLY BRAENDER PHONE NO : 011 45 44528100
MILEPARKEN 34 SE DECISION MADE: 13-JAN-05
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
B-K MEDICAL A/S 510(k) NO: K043554(SPECIAL)
ATTN: VILLY BRAENDER PHONE NO : 011 454 4528100
MILEPARKEN 34 SE DECISION MADE: 14-JAN-05
HERLEV, DENMARK DK-2730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAFLO BYPASS GRAFT
BARD PERIPHERAL VASCULAR, INC. 510(k) NO: K050049(SPECIAL)
ATTN: GLENN NORTON PHONE NO : 480-894-9515
1625 WEST 3RD ST. SE DECISION MADE: 31-JAN-05
P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85281
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (
BECTON, DICKINSON & CO. 510(k) NO: K043389(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 21-JAN-05
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNDSKIN PHOTOTHERAPY SYSTEM
BHC INTERNATIONAL, LTD. 510(k) NO: K040103(TRADITIONAL)
ATTN: MICHAEL BREEN PHONE NO : 708-366-6626
400 LATHROP AVENUE SE DECISION MADE: 18-JAN-05
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
RIVER FOREST, IL 60305
DEVICE: LIQUID ASSAYED MULTIQUAL CONTROL
BIO-RAD 510(k) NO: K043208(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1200
9500 JERONIMO RD. SE DECISION MADE: 07-JAN-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOGRAN-N-BONE VOID FILLER
BIOCOMPOSITES LTD. 510(k) NO: K043514(TRADITIONAL)
ATTN: STEPHEN BRATT PHONE NO : 44 178 2338580
KEELE SCIENCE PARK SE DECISION MADE: 21-JAN-05
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-0
BIOJECT MEDICAL TECHNOLOGIES INC. 510(k) NO: K043304(TRADITIONAL)
ATTN: LAURENCE A POTTER PHONE NO : 908-470-2800
211 SOMERVILLE ROAD SE DECISION MADE: 14-JAN-05
BEDMINSTER, NJ 07921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL
BIOMET MANUFACTURING CORP. 510(k) NO: K042321(TRADITIONAL)
ATTN: KACY ARNOLD PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 28-JAN-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
BIOMET, INC. 510(k) NO: K042774(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 21-JAN-05
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
BIOMET, INC. 510(k) NO: K043537(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 14-JAN-05
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
BIONIME CORPORATION 510(k) NO: K042678(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 03-JAN-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INBODY, MODEL 3.0
BIOSPACE CORPORATION LIMITED 510(k) NO: K042528(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 11-JAN-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-R-A-H-M-S PCT LIA
BRAHMS AKTIENGESELLSCHAFT 510(k) NO: K040887(TRADITIONAL)
ATTN: MELISSA MAHALL PHONE NO : 301-623-2500
11800 BALTIMORE AVE. SE DECISION MADE: 07-JAN-05
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BELTSVILLE, MD 20705
DEVICE: VECTORVISION ACL
BRAINLAB AG 510(k) NO: K042512(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
AMMERTHALSTRASSE 8 SE DECISION MADE: 13-JAN-05
HEIMSTETTEN, GERMANY 85551 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
C.R. BARD, INC. 510(k) NO: K043502(SPECIAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 14-JAN-05
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMP4 SELFCHECK ECG
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K042254(SPECIAL)
ATTN: BORIS ARADOVSKY PHONE NO : 972 8 9484000
2 PERERIS ST., SCIENCE PARK SE DECISION MADE: 13-JAN-05
REHOVOT, ISRAEL 76100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)
CARDIOBIOMEDICAL CORPORATION 510(k) NO: K042849(TRADITIONAL)
ATTN: JAMES F MONGIGARDO PHONE NO : 508-647-4065
2 BRIAR LANE SE DECISION MADE: 13-JAN-05
NATICK, MA 01760 510(k) STATEMENT
DEVICE: ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
CARDIOVASCULAR SYSTEMS INCORPORATE510(k) NO: K041630(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 31-JAN-05
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F00010 - IV GRAVITY SETWITH MALE LUER SLIP; F00027 - IV GRAVITY
CEDIC S.R.L. 510(k) NO: K042129(TRADITIONAL)
ATTN: GIANCARLO GAGLIARDONI PHONE NO : 003 902 55300174
VIA LIBERAZIONE, 63/9 SE DECISION MADE: 27-JAN-05
PESCHIERA BORROMEO MILAN(LOMB), IT510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMVIEW-10
CENOGENICS CORP. 510(k) NO: K042641(TRADITIONAL)
ATTN: NITZA KATZ PHONE NO : 732-536-6457
100 RT. 520 SE DECISION MADE: 07-JAN-05
MORGANVILLE, NJ 07751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADSTREAM VERSION 4.0
CONFIRMA, INC. 510(k) NO: K043216(TRADITIONAL)
ATTN: PATRICA A MILBANK PHONE NO : 425-894-9733
821 KIRKLAND AVE. SE DECISION MADE: 06-JAN-05
KIRKLAND, WA 98033-6318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMOVE 3000
CURATORONIC LTD. 510(k) NO: K042650(TRADITIONAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 976 70002
20 HATA'AS ST. SE DECISION MADE: 27-JAN-05
KFAR SABA 44425, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISSYS PEDICLE SCREW SYSTEM
CUSTOM SPINE, INC. 510(k) NO: K043522(TRADITIONAL)
ATTN: DEBBIE IAMPIETRO PHONE NO : 508-259-7374
PO BOX 1070 SE DECISION MADE: 14-JAN-05
CONWAY, NH 03818 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
CUTERA, INC. 510(k) NO: K050069(TRADITIONAL)
ATTN: KATHY MAYNOR PHONE NO : 415-657-5586
3240 BAYSHORE BLVD. SE DECISION MADE: 31-JAN-05
BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BEWELL, MODEL SC 20
CYCLING AND HEALTH TECH. INDUSTRY 510(k) NO: K043326(TRADITIONAL)
ATTN: CHANG WAN LAN PHONE NO : 886 4 23501100
NO. 17 RD. SE DECISION MADE: 26-JAN-05
TAICHUNG INDUSTRY PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: CYNERGY LASER
CYNOSURE, INC. 510(k) NO: K043429(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 12-JAN-05
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMIT II PLUS ECSTASY ASSAY
DADE BEHRING, INC. 510(k) NO: K043028(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
P.O. BOX 6101 SE DECISION MADE: 07-JAN-05
M/S 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE
DADE BEHRING, INC. 510(k) NO: K043546(SPECIAL)
ATTN: STANLEY GORAK PHONE NO : 302-631-7458
500 GBC DR., M/S 514 SE DECISION MADE: 18-JAN-05
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: READMYHEART
DAILYCARE BIOMEDICAL INC 510(k) NO: K042814(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340
3892 S. AMERICA WEST TRAIL SE DECISION MADE: 06-JAN-05
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEREBRAL STATE MONITOR - CSM
DANMETER A/S 510(k) NO: K042315(TRADITIONAL)
ATTN: HANNE NIELSEN PHONE NO : 45 63 112930
KILDEMOSEVEJ 13 SE DECISION MADE: 21-JAN-05
ODENSE C, DENMARK DK-5000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESCREEN APNEA
DEL MAR REYNOLDS MEDICAL, INC. 510(k) NO: K042745(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 19-JAN-05
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LDL-EX SEIKEN ASSAY KIT
DENKA SEIKEN CO., LTD. 510(k) NO: K043264(TRADITIONAL)
ATTN: TOSHIMI MATSUNAGA PHONE NO : 81 250 427221
1-2-2, MINAMIHONCHO SE DECISION MADE: 26-JAN-05
GOSEN-SHI, NIIGATA, JAPAN 959-1695510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITY 70 X-RAY
DENTAL X-RAY E.U. 510(k) NO: K043136(TRADITIONAL)
ATTN: GEORGE ECHEVERRI PHONE NO : 305-640-9894
1460 NW 107 AVE SUITE G SE DECISION MADE: 06-JAN-05
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K043113(ABBREVIATED)
ATTN: CLAUDIA S SWANSON PHONE NO : 574-371-4989
700 ORTHOPAEDIC DR. SE DECISION MADE: 21-JAN-05
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: DVI CURING LIGHT
DESIGNS FOR VISION, INC. 510(k) NO: K043530(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 25-JAN-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACETAMINOPHEN-SL ASSAY
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K042330(TRADITIONAL)
ATTN: NANCY OLSCAMP PHONE NO : 800 565 0265
16 MCCARVILLE ST. SE DECISION MADE: 07-JAN-05
WEST ROYALTY INDUSTRIAL PARK 510(k) STATEMENT
CHARLOTTETOWN, PRINCE EDWARD, CANADA C1E 2A6
DEVICE: INFINITY GATEWAY SUITE, VF4
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K043549(SPECIAL)
ATTN: PENELOPE H GRECO PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 21-JAN-05
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNATRON IBOX IONTOPHORESIS DEVICE
DYNATRONICS CORP. 510(k) NO: K043047(TRADITIONAL)
ATTN: RONALD J HATCH PHONE NO : 800-874-6251
7030 PARK CENTRE DR. SE DECISION MADE: 07-JAN-05
SALT LAKE CITY, UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODEL
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K043065(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949-250-2662
ONE EDWARDS WAY SE DECISION MADE: 26-JAN-05
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEODESIC PHOTOGRAMMETRY SYSTEM
ELECTRICAL GEODESICS, INCORPORATED510(k) NO: K043309(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541-345-5431
29611 SIMMONS ROAD SE DECISION MADE: 26-JAN-05
EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAM MODULATOR, MODEL 4513 332 8000
ELEKTA LTD. 510(k) NO: K042794(TRADITIONAL)
ATTN: PETER STEGAGNO PHONE NO : 770-300-9725
4775 PEACHTREE INDUSTRIAL BLVD SE DECISION MADE: 31-JAN-05
BLDG. 300, SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: ELEKTA NEUROMAG WITH MAXWELL FILTER
ELEKTA NEUROMAG OY 510(k) NO: K050035(SPECIAL)
ATTN: LOUISE LINDBLAD PHONE NO : 011 468 58725400
KUNGSTENSGATAN 18 SE DECISION MADE: 25-JAN-05
PO BOX 7593 510(k) SUMMARY AVAILABLE FROM FDA
STOCKHOLM, SWEDEN SE-103 93
DEVICE: INFINITY PLUS ELECTROTHERAPY SYSTEM
EMPI 510(k) NO: K041920(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 21-JAN-05
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDO TWINN
ENDO TWINN B.V. 510(k) NO: K042870(TRADITIONAL)
ATTN: F.M. VERHOEVEN PHONE NO : 31 20 4867571
DANZIGERKADE 17 SE DECISION MADE: 11-JAN-05
AMSTERDAM, NETHERLANDS 1013 AP 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K034026(TRADITIONAL)
ATTN: ADELE BINDON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 12-JAN-05
AUCKLAND, NEW ZEALAND 1701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT STAT MYO IMMUNOASSAY
FISHER DIAGNOSTICS 510(k) NO: K042924(TRADITIONAL)
ATTN: JOSEFINA INFANTAS PHONE NO : 540-974-1082
8365 VALLEY PIKE, PO BX 307 SE DECISION MADE: 24-JAN-05
MIDDLETOWN, VA 22645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWMEDIC, MODEL 220
FLOWMEDIC (ISRAEL) LTD 510(k) NO: K042217(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 13TH STREET, N.W. SE DECISION MADE: 12-JAN-05
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
FUTURE MEDICAL SYSTEMS, SA 510(k) NO: K041824(TRADITIONAL)
ATTN: PATRICK JANIN PHONE NO : 33 4 92123256
265 ROUTE DE LA BARONNE SE DECISION MADE: 07-JAN-05
ST. JEANNET, FRANCE 06640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
GAMBRO RENAL PRODUCTS 510(k) NO: K042938(SPECIAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 WEST COLLINS AVE. SE DECISION MADE: 06-JAN-05
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC TION GINGIVAL PROTECTOR
GC AMERICA, INC. 510(k) NO: K043301(TRADITIONAL)
ATTN: TERRY JORITZ PHONE NO : 708-597-0900
3737 WEST 127TH ST. SE DECISION MADE: 25-JAN-05
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: FUSION FAST
GC AMERICA, INC. 510(k) NO: K043471(TRADITIONAL)
ATTN: TERRY L JORITZ PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 27-JAN-05
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GE SIGNA EXCITE MR SURGICAL OPTION
GE HEALTHCARE 510(k) NO: K043262(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
W-400 SE DECISION MADE: 12-JAN-05
P.O. BOX 414 510(k) SUMMARY AVAILABLE FROM FDA
MILWAUKEE, WI 53201
DEVICE: CENTRICITY PACS SYSTEM
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K043415(TRADITIONAL)
ATTN: CAROL ALLOIAN PHONE NO : 847-704-3060
800 BUSINESS CENTER DR. SE DECISION MADE: 21-JAN-05
MOUNT PROSPECT, IL 60056 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL
GE MEDICAL SYSTEMS, LLC 510(k) NO: K042602(SPECIAL)
ATTN: MARK M STAUFFER PHONE NO : 262-544-3217
P.O. BOX 414 SE DECISION MADE: 13-JAN-05
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
GEN-PROBE, INC. 510(k) NO: K043072(TRADITIONAL)
ATTN: ALAN MADERAZO PHONE NO : 858-410-8332
10210 GENETIC CENTER DR. SE DECISION MADE: 27-JAN-05
SAN DIEGO, CA 92121-4362 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
GENESIS MEDICAL L.L.C. 510(k) NO: K043346(TRADITIONAL)
ATTN: PERRY GEREMAKIS PHONE NO : 201-337-6184
2650 US HIGHWAY 130 SE DECISION MADE: 31-JAN-05
CRANBURY, NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANTHERA N POWDER FREE BLACK NITRILE GLOVES
GLOVCO (M) SDN. BHD. 510(k) NO: K042898(TRADITIONAL)
ATTN: TAN PENG HOCK PHONE NO : 603 329 13888
LOT 760(BLOCK A),JALAN HAJI SE DECISION MADE: 18-JAN-05
SIRAT OFF JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR D.E., MALAYSIA 42100
DEVICE: LAPAROCISION SCOPE CONTROLLER SYSTEM
GMP/COMPANIES, INC. 510(k) NO: K050027(TRADITIONAL)
ATTN: RALPH JUGO PHONE NO : 954-745-7694
ONE EAST BROWARD BLVD. SE DECISION MADE: 27-JAN-05
SUITE 1701 510(k) SUMMARY AVAILABLE FROM FDA
FORT LAUDERDALE, FL 33301 THIRD PARTY REVIEW
DEVICE: HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
HAEMONETICS CORP. 510(k) NO: K043127(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 781-356-9553
400 WOOD RD. SE DECISION MADE: 04-JAN-05
P.O. BOX 9114 510(k) SUMMARY AVAILABLE FROM FDA
BRAINTREE, MA 02184
DEVICE: FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
HEALTH & LIFE CO., LTD. 510(k) NO: K043437(SPECIAL)
ATTN: PAUL HUNG PHONE NO : 886 2 82271300
9F, NO.186, JIAN YI ROAD SE DECISION MADE: 12-JAN-05
CHUNG HO CITY, TAIPEI, CHINA (TAIW510(k) STATEMENT
DEVICE: VERSYO.DIRECT
HERAEUS KULZER, INC. 510(k) NO: K043295(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 05-JAN-05
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: PALAIMPACT
HERAEUS KULZER, INC. 510(k) NO: K043504(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-291-0661
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 28-JAN-05
SOUTH BEND, IN 46614-2517 510(k) STATEMENT
DEVICE: HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR
HOME HEALTH TECHNOLOGY CO., LTD. 510(k) NO: K043376(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 10-JAN-05
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
HOWMEDICA OSTEONICS CORP 510(k) NO: K042993(TRADITIONAL)
ATTN: DENISE DUCHENE PHONE NO : 201-831-5612
325 COMMERCE COURT SE DECISION MADE: 12-JAN-05
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SOAKER CATHETER
I-FLOW CORP. 510(k) NO: K043456(SPECIAL)
ATTN: SHANE NOEHRE PHONE NO : 949-206-2700
20202 WINDROW DR. SE DECISION MADE: 11-JAN-05
LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-PROMOTIONS CONTACT LENS CASE
I-PROMOTIONS, INC. 510(k) NO: K042578(TRADITIONAL)
ATTN: CHARLOTTE SLANKARD PHONE NO : 314-638-1900
9522 GRAVOIS RD. SE DECISION MADE: 25-JAN-05
ST. LOUIS, MO 63123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTISTRAND, MODEL 1032S
IBT SA 510(k) NO: K043336(TRADITIONAL)
ATTN: RUTH FEICHT PHONE NO : 770-582-0662
6000 LIVE OAK PARKWAY, STE 107 SE DECISION MADE: 21-JAN-05
NORCROSS, GA 30093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT SCIENCES CORP, MODEL HDR-4140
IMPLANT SCIENCES CORP. 510(k) NO: K042864(TRADITIONAL)
ATTN: JOHN J MUNRO PHONE NO : 781-246-0700
107 AUDUBON ROAD, #5 SE DECISION MADE: 06-JAN-05
WAKEFIELD, MA 01880-1246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
IMTEC CORP. 510(k) NO: K043226(TRADITIONAL)
ATTN: J. BRAD VANCE PHONE NO : 580-223-4456
2401 NORTH COMMERCE SE DECISION MADE: 13-JAN-05
ARDMORE, OK 73401 510(k) STATEMENT
DEVICE: FUNHALER, MODEL FH 101
INFAMED LTD. 510(k) NO: K042546(ABBREVIATED)
ATTN: JOHN D GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH STREET SE DECISION MADE: 03-JAN-05
FORT LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2-MRI ANALYSIS SYSTEM
INNER VISION BIOMETRICS PTY LTD 510(k) NO: K043271(TRADITIONAL)
ATTN: JANET PREUSS PHONE NO : 618 928 65307
216 STIRLING HWY SE DECISION MADE: 21-JAN-05
CLAREMONT, PERTH, AUSTRALIA 6010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IXL-II DIABETES MANAGEMENT SYSTEM
INSULET CORPORATION 510(k) NO: K042792(TRADITIONAL)
ATTN: A. ARTHUR RANKIS PHONE NO : 781-457-5000
9 OAK PARK DRIVE SE DECISION MADE: 03-JAN-05
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURAGEN II DURAL REGENERATION MATRIX
INTEGRA LIFESCIENCES CORP. 510(k) NO: K043427(SPECIAL)
ATTN: DIANA M BORDON PHONE NO : 609-275-0500
105 MORGAN LANE SE DECISION MADE: 12-JAN-05
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP
INTUITIVE SURGICAL, INC. 510(k) NO: K050005(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 25-JAN-05
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVACARE PRO, COMPACT AND PORTABLE DESKTOP
INVACARE CORPORATION 510(k) NO: K042483(TRADITIONAL)
ATTN: CARROLL MARTIN PHONE NO : 440-329-6356
ONE INVACARE WAY SE DECISION MADE: 06-JAN-05
ELYRIA, OH 44035-4190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
INVATEC INNOVATIVE TECHNOLOGIES, S510(k) NO: K042624(TRADITIONAL)
ATTN: MIKE WINEGAR PHONE NO : 763-398-7225
4600 NATHAN LANE NORTH SE DECISION MADE: 10-JAN-05
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
INVIVO RESEARCH, INC. 510(k) NO: K043354(SPECIAL)
ATTN: NEIL BATTISTE PHONE NO : 800-331-3220
12601 RESEARCH PKWY. SE DECISION MADE: 10-JAN-05
ORLANDO, FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILLI GELLER CREATION ZI PORCELAIN
JENSEN INDUSTRIES, INC. 510(k) NO: K043201(ABBREVIATED)
ATTN: GARY PHELPS PHONE NO : 203-239-2090
50 STILLMAN RD. SE DECISION MADE: 11-JAN-05
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WILLI GELLER CREATION II PORCELAIN
JENSEN INT'L, INC. 510(k) NO: K043468(ABBREVIATED)
ATTN: GARY PHELPS PHONE NO : 203-239-2090
50 STILLMAN ROAD SE DECISION MADE: 12-JAN-05
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINET KIT
JORDAN NEUROSCIENCE, INC. 510(k) NO: K043009(TRADITIONAL)
ATTN: ANNE PERRY PHONE NO : 909-881-2694
399 E. HIGHLAND AVE., STE 316 SE DECISION MADE: 12-JAN-05
SAN BERNARDINO, CA 92404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENALI SPINE SYSTEM
K2M, LLC 510(k) NO: K042635(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DRIVE SE, SUITE F1 SE DECISION MADE: 10-JAN-05
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FISCH TITANIUM MIDDLE EAR PROSTHESES
KARL STORZ ENDOSCOPY 510(k) NO: K043375(TRADITIONAL)
ATTN: YVONNE FERNANDEZ PHONE NO : 310-348-4226
600 CORPORATE POINTE SE DECISION MADE: 24-JAN-05
5TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CULVER CITY, CA 90230-7600
DEVICE: IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
KAVO AMERICA 510(k) NO: K050019(TRADITIONAL)
ATTN: JOHN R MILLER PHONE NO : 800-323-8029
340 EAST MAIN ST. SE DECISION MADE: 31-JAN-05
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. GRANUFOAM SILVER DRESSING
KINETIC CONCEPTS, INC. 510(k) NO: K041642(TRADITIONAL)
ATTN: JUDITH HARBOUR PHONE NO : 210-255-4468
P.O. BOX 659508 SE DECISION MADE: 25-JAN-05
SAN ANTONIO, TX 78265-9508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
KONTRON MEDICAL SYSTEMS SAS 510(k) NO: K050099(ABBREVIATED)
ATTN: GEORGINA FABIAN PHONE NO : 973-839-8669
9J BROOKSIDE HEIGHTS SE DECISION MADE: 28-JAN-05
WANAQUE, NJ 07465 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BF+
LDR SPINE USA 510(k) NO: K043347(TRADITIONAL)
ATTN: BRIAN BURKINSHAW PHONE NO : 512-437-4311
108 WILD BASIN ROAD SE DECISION MADE: 07-JAN-05
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LSA HELIUM
LIFESTAND 510(k) NO: K042596(TRADITIONAL)
ATTN: STEFANIE D BANKSTON PHONE NO : 281-464-7558
10925 BEAMER #290 SE DECISION MADE: 26-JAN-05
HOUSTON, TX 77089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINN-ACL CROSSPIN
LINVATEC CORP. 510(k) NO: K043106(TRADITIONAL)
ATTN: ELIZABETH M PAUL PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 19-JAN-05
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO OUTBACK CATHETER
LUMEND, INC. 510(k) NO: K043534(SPECIAL)
ATTN: MICHAEL A DANIEL PHONE NO : 650-364-1400
400 CHESAPEAKE DR. SE DECISION MADE: 21-JAN-05
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM S
LUMENIS, LTD. 510(k) NO: K043173(TRADITIONAL)
ATTN: MARTHA MURARI PHONE NO : 408-764-3604
2400 CONDENSA ST. SE DECISION MADE: 31-JAN-05
SANTA CLARA, CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOODKNIGHT H20, MODEL M-114600-00
MALLINCKRODT DEVELOPPEMENT FRANCE 510(k) NO: K042184(TRADITIONAL)
ATTN: MOUSTAFA ANKI PHONE NO : 333 834 48500
10 ALLEE PELLETIER DOISY SE DECISION MADE: 10-JAN-05
VILLERS-LES-NANCY, FRANCE 54601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INFANT FEEDING TUBE
MARIAN MEDICAL, INC. 510(k) NO: K042112(TRADITIONAL)
ATTN: SANDY WINKLER PHONE NO : 502-552-6189
PO BOX 5193 SE DECISION MADE: 28-JAN-05
DESTIN, FL 32540 510(k) STATEMENT
DEVICE: MASIMO SET RAD 57 PULSE CO-OXIMETER
MASIMO CORPORATION 510(k) NO: K042536(TRADITIONAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 19-JAN-05
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
MATSUSHITA ELECTRIC WORKS, LTD. 510(k) NO: K042818(SPECIAL)
ATTN: CAROLANN KOTULA PHONE NO : 516-482-9001
55 NORTHERN BLVD. SE DECISION MADE: 27-JAN-05
SUITE 200 510(k) STATEMENT
GREAT NECK, NY 11021
DEVICE: HORIZON MEDICAL IMAGING
MCKESSON MEDICAL IMAGING COMPANY 510(k) NO: K043146(TRADITIONAL)
ATTN: ROBERT MACNEIL PHONE NO : 604 279 5422
130-10711 CAMBIE ROAD SE DECISION MADE: 04-JAN-05
RICHMOND, B.C., CANADA V6X 3G5 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
MEDELA AG 510(k) NO: K043544(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151
LAETTICHSTRASSE 7 SE DECISION MADE: 07-JAN-05
BAAR, ZUG, SWITZERLAND 6341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PHARMGUARD TOOLBOX, MODEL G6000782
MEDEX, INC. 510(k) NO: K042432(TRADITIONAL)
ATTN: BARBARA LAW PHONE NO : 614-889-2220
6250 SHIER RINGS RD. SE DECISION MADE: 04-JAN-05
DUBLIN, OH 40316 510(k) STATEMENT
DEVICE: MEDICON VIPAIR HIGH SPEED SYSTEM
MEDICON, E.G. 510(k) NO: K042974(TRADITIONAL)
ATTN: JOACHIM SCHMID PHONE NO : 49 746 220090
GAENSAECKER 15 SE DECISION MADE: 13-JAN-05
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDIN TECH ZIRCONIA-CP10, SS1000
MEDIN TECH 510(k) NO: K043472(TRADITIONAL)
ATTN: ABDESLAM KASSEH PHONE NO : 514 334 9420
6644 ABRAMS SE DECISION MADE: 18-JAN-05
ST-LAURENT (PQ), CANADA H4S 1Y1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC STRATAVARIUS
MEDTRONIC NEUROSURGERY 510(k) NO: K041992(TRADITIONAL)
ATTN: JEFF HENDERSON PHONE NO : 805-968-1546
125 CREMONA DR. SE DECISION MADE: 28-JAN-05
GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLAXY 3.2 SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043020(TRADITIONAL)
ATTN: RICHARD TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 07-JAN-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043566(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 07-JAN-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUESTRA FLUID DELIVERY SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K043568(SPECIAL)
ATTN: RICHARD W TREHARNE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-JAN-05
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE
MEDTRONIC SURGICAL NAVIGATION TECH510(k) NO: K043088(TRADITIONAL)
ATTN: TINA DREILING PHONE NO : 720-890-3217
826 COAL CREEK CIR. SE DECISION MADE: 05-JAN-05
LOUISVILLE, CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON ANGIO
MENNEN MEDICAL LTD. 510(k) NO: K043564(SPECIAL)
ATTN: MICHA OESTEREICH PHONE NO : 011 972 89323333
4 HA-YARDEN ST. SE DECISION MADE: 27-JAN-05
P.O. BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
YAVNE, REHOVOT, ISRAEL 81228
DEVICE: LAPAX 2000
MERIDIAN CO., LTD. 510(k) NO: K034009(ABBREVIATED)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 21-JAN-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
MONDEAL MEDICAL SYSTEMS GMBH 510(k) NO: K042345(ABBREVIATED)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 4289591
AMSTEL 320-1 SE DECISION MADE: 13-JAN-05
AMSTERDAM, NETHERLANDS 1017AP 510(k) STATEMENT
DEVICE: AIRSTRIP OB
MP4 SOLUTIONS, LP 510(k) NO: K042082(TRADITIONAL)
ATTN: WILLIAM CAMERON POWELL PHONE NO : 210-392-5232
11 LYNN BATTS LANE SE DECISION MADE: 21-JAN-05
SAN ANTONIO, TX 78218 510(k) STATEMENT
DEVICE: MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0
NEUROGNOSTICS, INC. 510(k) NO: K043290(TRADITIONAL)
ATTN: HRISHIKESH GADAGKAR PHONE NO : 414-727-7950
10437 INNOVATION DR. SE DECISION MADE: 28-JAN-05
SUITE 309 510(k) STATEMENT
MILWAUKEE, WI 53226
DEVICE: NEUROMONICS TINNITUS TREATMENT
NEUROMONICS PTY LTD 510(k) NO: K043274(TRADITIONAL)
ATTN: BEN MCSWEENEY PHONE NO : 612 941 04300
UNIT 10-11/56 NERIDAH ST SE DECISION MADE: 28-JAN-05
CHATSWOOD, AUSTRALIA NSW 2067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOFAX CE, MODEL PEA-1110K
NIHON KOHDEN AMERICA, INC. 510(k) NO: K042827(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 06-JAN-05
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
NOBLE FIBER TECHNOLOGIES 510(k) NO: K033900(TRADITIONAL)
ATTN: PATRICIA DAVIDSON PHONE NO : 877-978-2842
421 S. STATE ST. SE DECISION MADE: 14-JAN-05
CLARKS SUMMIT, PA 18411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4100 PATIENT OXIMETER MODULE
NONIN MEDICAL, INC. 510(k) NO: K043359(TRADITIONAL)
ATTN: JOHN R DALPEE PHONE NO : 763-577-3166
2605 FERNBROOK LANE, NORTH SE DECISION MADE: 07-JAN-05
MINNEAPOLIS, MN 55447-4755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CZR PRESS LF
NORITAKE CO., INC. 510(k) NO: K043462(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-342-8400
3050 K STREET, NW, STE 400 SE DECISION MADE: 11-JAN-05
WASHINGTON, DC 20007 510(k) STATEMENT
DEVICE: NOVA-PULSE
NOVA RANGER, INC. 510(k) NO: K043302(SPECIAL)
ATTN: CURTIS M EGAN PHONE NO : 858-675-8200
16787 BERNARDO CENTER DRIVE SE DECISION MADE: 03-JAN-05
# A-1 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92128
DEVICE: VISTA PLUS
NOVACOR 510(k) NO: K042108(TRADITIONAL)
ATTN: DOMINIQUE GRENIER PHONE NO : 33 1 41390578
4, PASSAGE SAINT-ANTOINE SE DECISION MADE: 19-JAN-05
RUEIL MALMAISON CEDEX, FRANCE 9250510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K042961(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822
2585 SKYMARK AVE., STE: 306 SE DECISION MADE: 19-JAN-05
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACHYCAM
OCULUS OPTIKGERATE GMBH 510(k) NO: K041841(TRADITIONAL)
ATTN: JOERG IWANCZUK PHONE NO : 011 496 4120050
MUNCHHOLZHAUSER STRASSE 29 SE DECISION MADE: 28-JAN-05
WETZLA-DUTENHOFEN, GERMANY D-35582510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
OLYMPUS AMERICA, INC. 510(k) NO: K043460(ABBREVIATED)
ATTN: BEV HARDING PHONE NO : 972-556-9697
3131 WEST ROYAL LN. SE DECISION MADE: 31-JAN-05
IRVING, TX 75063-3104 510(k) STATEMENT
DEVICE: R605 FACS COLLIMETER
OMEGA MEDICAL IMAGING, INC. 510(k) NO: K050092(TRADITIONAL)
ATTN: JAMES A PRINCEHOM PHONE NO : 407-323-9400
675 HICKMAN CIRCLE SE DECISION MADE: 31-JAN-05
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
OMRON HEALTHCARE, INC. 510(k) NO: K043060(TRADITIONAL)
ATTN: LARRY LEPLEY PHONE NO : 847-680-6200
1200 LAKESIDE DRIVE SE DECISION MADE: 19-JAN-05
BANNOCKBURN, IL 60015 510(k) STATEMENT
DEVICE: OCT-OPTHALMOSCOPE
OPHTHALMIC TECHNOLOGIES, INC. 510(k) NO: K042885(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 210-727-1703
377 RT 17 S SE DECISION MADE: 21-JAN-05
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFO
OPTI-CENTRE LABORATORIES 510(k) NO: K043129(TRADITIONAL)
ATTN: BONNIE TSYMBAL PHONE NO : 585-264-3210
711 NORTH ROAD SE DECISION MADE: 12-JAN-05
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
ORAL OSTEODISTRACTION, L.P. 510(k) NO: K042278(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LN. SE DECISION MADE: 28-JAN-05
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLITUDE UNIPOLAR HEAD
ORTHO DEVELOPMENT CORP. 510(k) NO: K042973(TRADITIONAL)
ATTN: WILLIAM J GRIFFIN PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 27-JAN-05
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CH
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K042479(TRADITIONAL)
ATTN: CAREY A MAYO PHONE NO : 585-453-3482
100 INDIGO CREEK DR. SE DECISION MADE: 06-JAN-05
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
ORTHOSOFT, INC. 510(k) NO: K043536(SPECIAL)
ATTN: CHRISTOPHER MCLEAN PHONE NO : 514 861 4074
75 QUEEN ST., SUITE 3300 SE DECISION MADE: 14-JAN-05
MONTREAL, QUEBEC, CANADA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUGRAFT BGS SYRINGE, MODEL 600-041
OSTEOBIOLOGICS, INC. 510(k) NO: K043172(TRADITIONAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-690-2131
UNIVERSITY BUSINESS PARK SE DECISION MADE: 07-JAN-05
12500 NETWORK, SUITE 112 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249-3308
DEVICE: Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
OSTEOIMPLANT TECHNOLOGY, INC. 510(k) NO: K040685(TRADITIONAL)
ATTN: SAM SON PHONE NO : 410-785-0700
11201 PEPPER RD. SE DECISION MADE: 25-JAN-05
HUNT VALLEY, MD 21031-1201 510(k) STATEMENT
DEVICE: PALOMAR STARLUX PULSED LIGHT SYSTEM
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K041086(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LN. SE DECISION MADE: 13-JAN-05
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LUX1064 HANDPIECE
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K041879(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919-363-2432
131 KELEKENT LN. SE DECISION MADE: 13-JAN-05
CARY, NC 27511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
PANORAMIC CORP. 510(k) NO: K043557(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 13-JAN-05
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PFA PATCH
PERITEC BIOSCIENCES, LLC. 510(k) NO: K041736(TRADITIONAL)
ATTN: ROBERT M DICKSON PHONE NO :
3291 BREMERTON ROAD SE DECISION MADE: 13-JAN-05
CLEVELAND, OH 44124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODYSSEY
PERMEDICS, INC. 510(k) NO: K042861(TRADITIONAL)
ATTN: JESSICA CONNOR PHONE NO : 909-478-5000
1475 SOUTH VICTORIA CT. SE DECISION MADE: 12-JAN-05
SAN BERNARDINO, CA 92408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN
PETER STEVENS, MD 510(k) NO: K033856(TRADITIONAL)
ATTN: PETER STEVENS, MD PHONE NO : 801-588-3900
PO BOX 58246 SE DECISION MADE: 07-JAN-05
SALT LAKE CITY, UT 84158 510(k) STATEMENT
DEVICE: HD11 DIAGNOSTIC ULTRASOUND SYSTEM
PHILIPS ULTRASOUND, INC. 510(k) NO: K043535(TRADITIONAL)
ATTN: STEVE SINGLAR PHONE NO : 978-659-2101
3000 MINUTEMAN RD. SE DECISION MADE: 06-JAN-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMT.LAB
PIE MEDICAL 510(k) NO: K043360(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 05-JAN-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYLAB 15 / MYLAB 20, MODEL 2700
PIE MEDICAL 510(k) NO: K043588(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-849-1916
7992 CASTLEWAY DRIVE SE DECISION MADE: 25-JAN-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPA
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K043206(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 21-JAN-05
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLASIATEK ACTUATOR
PLASIATEK, LLC 510(k) NO: K041917(TRADITIONAL)
ATTN: PAUL PESEK PHONE NO : 952-593-9960
10560 WAYZATA BLVD. SE DECISION MADE: 07-JAN-05
MINNEAPOLIS, MN 55305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K042567(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 626 179 41463
JL.BATANG KUIS GG.TAMBAK REJO SE DECISION MADE: 13-JAN-05
DESA BUNTU BEDIMBAR TJ. MORAWA 510(k) STATEMENT
MEDAN, NORTH SUMATERA, INDONESIA 20362
DEVICE: MODIFICATION TO: RADIANALYZER, MODEL 12711
RADI MEDICAL SYSTEMS AB 510(k) NO: K042628(TRADITIONAL)
ATTN: HELENE EKSTRAND PHONE NO : 461 816 2004
PALMBLADSGATAN 10 SE DECISION MADE: 19-JAN-05
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANDOX PHENCYCLIDINE ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K043071(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 27-JAN-05
CRUMLIN, COUNTY ANTRIM, UNITED KIN510(k) STATEMENT
DEVICE: BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
RESPIRONICS, INC. 510(k) NO: K043607(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 28-JAN-05
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
ROCHE DIAGNOSTICS 510(k) NO: K050026(SPECIAL)
ATTN: THERESA M AMBROSE PHONE NO : 317-521-3723
9115 HAGUE ROAD PO BOX 50457 SE DECISION MADE: 31-JAN-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONLINE DAT PHENCYCLIDINE PLUS
ROCHE DIAGNOSTICS CORP. 510(k) NO: K043305(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 10-JAN-05
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE AMPLICHIP CYP450 TEST
ROCHE MOLECULAR SYSTEMS, INC. 510(k) NO: K043576(TRADITIONAL)
ATTN: JAMES F KELLY PHONE NO : 925-730-8180
4300 HACIENDA DRIVE SE DECISION MADE: 10-JAN-05
PLEASANTON, CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAN-MAR LABS LUBRICATING JELLY
SAN-MAR LABORATORIES, INC. 510(k) NO: K041667(TRADITIONAL)
ATTN: SIMON SANDERS PHONE NO : 914-592-3130
4 WAREHOUSE LN. SE DECISION MADE: 13-JAN-05
ELMSFORD, NY 10523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE, RELEASE 5.5
SEGAMI CORPORATION 510(k) NO: K043441(SPECIAL)
ATTN: PHILIPPE BRIANDET PHONE NO : 410-381-2311
8325 GUILFORD RD., SUITE B SE DECISION MADE: 13-JAN-05
COLUMBIA, MD 21046 510(k) STATEMENT
DEVICE: NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VA
SGMP CO., LTD. 510(k) NO: K042879(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 13-JAN-05
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PM-8000 PATIENT MONITOR
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K043348(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 06-JAN-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K043563(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-JAN-05
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH
SHIJIAZHUANG TILLOTSON RUBBER PROD510(k) NO: K043014(TRADITIONAL)
ATTN: JAMES CHU PHONE NO : 714-990-6888
590 W. CENTRAL AVENUE SE DECISION MADE: 28-JAN-05
SUITE D 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
SHIJIAZHUANG WINFUL PLASTIC CO., L510(k) NO: K043477(TRADITIONAL)
ATTN: CHEN YUHONG PHONE NO : 861 065 666660125
NO. 10B CENTRAL ROAD, AVIC BLD SE DECISION MADE: 07-JAN-05
EAST 3RD RING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
CHAOYANG DISTRICT, BEIJING, CHINA 10002
DEVICE: MAMMOREPORT SOFTCOPY WORKSTATION
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K042868(SPECIAL)
ATTN: DEBRA PEACOCK PHONE NO : 610-448-1773
51 VALLEY STREAM PKWY. SE DECISION MADE: 06-JAN-05
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K050034(TRADITIONAL)
ATTN: PATRICK LYNCH PHONE NO : 425-557-1825
22010 S.E. 51ST ST. SE DECISION MADE: 13-JAN-05
ISSAQUAH, WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALOCLAIR ORAL SPRAY
SINCLAIR PHARMACEUTICALS, LTD. 510(k) NO: K042722(TRADITIONAL)
ATTN: MICHAEL KILLEEN PHONE NO : 44 148 3428611
BOROUGH RD. SE DECISION MADE: 13-JAN-05
GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMADEUS II EPIKERATOME
SIS LTD. SURGICAL INSTRUMENT SYSTE510(k) NO: K043150(SPECIAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 31-JAN-05
LITTLETON, CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW HYBRID KNEE FEMORAL
SMITH & NEPHEW, INC. 510(k) NO: K042896(ABBREVIATED)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1450 E. BROOKS RD. SE DECISION MADE: 12-JAN-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CABLING SYSTEM TROCHANTER HOOK
SMITH & NEPHEW, INC. 510(k) NO: K043252(TRADITIONAL)
ATTN: JOHN REABE PHONE NO : 901-399-6670
1450 E. BROOKS RD. SE DECISION MADE: 14-JAN-05
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW VIDEOARTHROSCOPE
SMITH & NEPHEW, INC. 510(k) NO: K043395(TRADITIONAL)
ATTN: KATHLEEN BURNS PHONE NO : 978-474-6301
150 MINUTEMAN RD. SE DECISION MADE: 12-JAN-05
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIN, MODEL V 3.0
SOHARD AG 510(k) NO: K043483(TRADITIONAL)
ATTN: JOAN C MAZUR PHONE NO : 610-789-7000
2500 W. TOWNSHIP LINE ROAD SE DECISION MADE: 28-JAN-05
HAVERTOWN, PA 19083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES
SONOSITE,INC. 510(k) NO: K043559(TRADITIONAL)
ATTN: DAINA L GRAHAM PHONE NO : 425-951-1275
21919 30TH DRIVE SE. SE DECISION MADE: 12-JAN-05
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPSMEDICAL SPORVIEW PA CULTURE SET
SPS MEDICAL SUPPLY CORP. 510(k) NO: K043135(TRADITIONAL)
ATTN: GARY J SCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 13-JAN-05
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
ST. JUDE MEDICAL, DAIG DIVISION, I510(k) NO: K042623(SPECIAL)
ATTN: JENNIFER NEVISON PHONE NO : 952-351-1496
14901 DEVEAU PL. SE DECISION MADE: 27-JAN-05
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLAR 2 ANATOMIC SHOULDER
STRYKER ORTHOPAEDICS 510(k) NO: K040432(TRADITIONAL)
ATTN: GINNY STAMBERGER PHONE NO : 201-831-5467
325 CORPORATE DRIVE SE DECISION MADE: 07-JAN-05
MAHWAH, NJ 07432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO XIA SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K043473(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 12-JAN-05
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS NASAL CPAP MASK, 9354 SERIES
SUNRISE MEDICAL 510(k) NO: K042455(TRADITIONAL)
ATTN: ALLAN JONES PHONE NO : 814-443-7618
100 DEVILBISS DR. SE DECISION MADE: 14-JAN-05
SOMERSET, PA 15501-2125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SA
SYNTHES (USA) 510(k) NO: K043039(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 18-JAN-05
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) CHRONOS
SYNTHES (USA) 510(k) NO: K043045(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 07-JAN-05
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
SYNTHES (USA) 510(k) NO: K043310(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-647-9700
1690 RUSSELL RD. SE DECISION MADE: 05-JAN-05
PAOLI, PA 19301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUSCH EASY TUBE
TELEFLEX MEDICAL 510(k) NO: K043205(TRADITIONAL)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 07-JAN-05
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
THERAGENICS CORP. 510(k) NO: K043596(SPECIAL)
ATTN: BETSY CORTELLONI PHONE NO : 770-831-4294
5203 BRISTOL INDUSTRIAL WAY SE DECISION MADE: 26-JAN-05
BUFORD, GA 30518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAGE THERMACOOL SYSTEM
THERMAGE, INC. 510(k) NO: K043402(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
4058 POINT EDEN WAY SE DECISION MADE: 14-JAN-05
HAYWARD, CA 94545-3721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TM
TIARA MEDICAL SYSTEMS, INC. 510(k) NO: K043382(TRADITIONAL)
ATTN: GEOFFREY SLEEPER PHONE NO : 216-521-1220
14414 DETROIT AVE, SUITE 205 SE DECISION MADE: 19-JAN-05
LAKEWOOD, OH 44107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN DENTAL IMPLANT SYSTEM
TITAN IMPLANTS, INC. 510(k) NO: K042971(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
4329 GRAYDON ROAD SE DECISION MADE: 14-JAN-05
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-H
TOTOKU ELECTRIC CO., LTD 510(k) NO: K043430(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345484
300 OYA SE DECISION MADE: 28-JAN-05
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMED OSTEOTOMY PLATE
TRIMED, INC. 510(k) NO: K043263(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661-312-7150
28337 MAITLAND LANE SE DECISION MADE: 14-JAN-05
SAUGUS, CA 91350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
TYCO HEALTHCARE 510(k) NO: K042709(TRADITIONAL)
ATTN: WEI ZHAO PHONE NO : 508-261-8404
15 HAMPSHIRE ST. SE DECISION MADE: 18-JAN-05
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOSTATION-100 (CS-100)
US CLOVER CO. 510(k) NO: K041031(TRADITIONAL)
ATTN: CECILIA L YU PHONE NO : 626-964-6680
17800 CASTLETON STREET SE DECISION MADE: 26-JAN-05
SUITE 415 510(k) STATEMENT
CITY OF INDUSTRY, CA 91748
DEVICE: LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
VALLEYLAB 510(k) NO: K043273(TRADITIONAL)
ATTN: HERBERT VINSON PHONE NO : 303-530-6469
5920 LONGBOW DR. SE DECISION MADE: 05-JAN-05
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED PULSE OXIMETER SENSORS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K042316(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 06-JAN-05
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
VANGUARD MEDICAL CONCEPTS, INC. 510(k) NO: K042594(TRADITIONAL)
ATTN: HEATHER CRAWFORD PHONE NO : 863-683-8680
5307 GREAT OAK DR. SE DECISION MADE: 25-JAN-05
LAKELAND, FL 33815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K042937(SPECIAL)
ATTN: DEBORAH L NEYMARK PHONE NO : 763-656-4349
6464 SYCAMORE COURT NORTH SE DECISION MADE: 31-JAN-05
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
VASCUTEK LTD. 510(k) NO: K043552(SPECIAL)
ATTN: STEVEN ARICK PHONE NO : 734-663-4145
6200 JACKSON RD. SE DECISION MADE: 05-JAN-05
ANN ARBOR, MI 48103-9300 510(k) STATEMENT
DEVICE: PROXIS SYSTEM, MODEL EPS 101
VELOCIMED INC. 510(k) NO: K042117(SPECIAL)
ATTN: JOHN CARLINE PHONE NO : 763-463-4742
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 07-JAN-05
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55311
DEVICE: BC PLUS
VERICOM CO., LTD. 510(k) NO: K043562(TRADITIONAL)
ATTN: MYUNG-HWAN OH PHONE NO : 82 31 4412881
#606,5TH DONGYOUNG VENTURESTEL SE DECISION MADE: 03-JAN-05
199-32, ANYANG 7-DONG,MANAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG-SI, GYEONGGI-DO, REPUBLIC OTHIRD PARTY REVIEW
DEVICE: VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
VIOPTIX, INC. 510(k) NO: K042657(TRADITIONAL)
ATTN: GREG HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 10-JAN-05
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICSI-100
VITROLIFE SWEDEN AB 510(k) NO: K043116(TRADITIONAL)
ATTN: MORGAN HUGOSSON PHONE NO : 46 31 7218076
FAKTORVAGEN 13 SE DECISION MADE: 13-JAN-05
KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRITY, MODEL V500
VIVOSONIC, INC. 510(k) NO: K043396(TRADITIONAL)
ATTN: EDWARD GOSS PHONE NO : 416 231 9997
56 ABERFOYLE CRESCENT SE DECISION MADE: 24-JAN-05
SUITE 620 510(k) STATEMENT
TORONTO, ON, CANADA M8X 2W4 THIRD PARTY REVIEW
DEVICE: VOXAR 3D PRODUCT FAMILY
VOXAR LIMITED 510(k) NO: K043194(TRADITIONAL)
ATTN: NEIL PHILLIPS PHONE NO : 44 131 4724792
BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 11-JAN-05
EDINBURGH, UNITED KINGDOM EH6 5NP 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: ANEROID SPHYGMOMANOMETER, MODEL BK2002
WENZHOU BOKANG INSTRUMENT CO.,LTD 510(k) NO: K043286(TRADITIONAL)
ATTN: ZHANG JIAN PHONE NO : 504-909-9658
4413 GLENDALE ST. SE DECISION MADE: 13-JAN-05
METAIRIE, LA 70006 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COMPRESSION STAPLE AND SIMPLE STAPLE
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043059(TRADITIONAL)
ATTN: KATIE LOGEROT PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 18-JAN-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTI-USE COMPRESSION SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043102(TRADITIONAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 21-JAN-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043281(TRADITIONAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 19-JAN-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K043583(SPECIAL)
ATTN: WESLEY L REED PHONE NO : 901-867-4701
5677 AIRLINE RD. SE DECISION MADE: 26-JAN-05
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROGUM SOFT
ZHERMACK S.P.A. 510(k) NO: K043118(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 24-JAN-05
BEND, OR 97702 510(k) STATEMENT
DEVICE: SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02
ZIMMER GMBH 510(k) NO: K043270(TRADITIONAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523
P.O. BOX 708 SE DECISION MADE: 31-JAN-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
ZIMMER, INC. 510(k) NO: K043560(SPECIAL)
ATTN: LAURA D WILLIAMS PHONE NO : 574-372-4523
P.O. BOX 708 SE DECISION MADE: 21-JAN-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359
ZIMMER, INC. 510(k) NO: K050121(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 574-371-8552
P.O. BOX 708 SE DECISION MADE: 31-JAN-05
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 215
TOTAL WITH SUMMARIES 185
TOTAL WITH STATEMENTS 30
Updated September 26, 2005
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