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Medical Devices
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January 2009 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-JAN-2009 THROUGH 31-JAN-2009
DEVICE: QLASER SYSTEM
2035, INC. 510(k) NO: K080513(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 30-JAN-09
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE
A-DEC, INC. 510(k) NO: K082716(ABBREVIATED)
ATTN: THOMAS H LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 15-JAN-09
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
A-DEC, INC. 510(k) NO: K082827(ABBREVIATED)
ATTN: THOMAS H LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 07-JAN-09
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: RELIEVA STRATUS MICROFLOW SPACER
ACCLARENT, INC. 510(k) NO: K083574(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874
1525-B O'BRIEN DR. SE DECISION MADE: 29-JAN-09
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-SCREEN
ADDENT, INC. 510(k) NO: K082668(TRADITIONAL)
ATTN: JOSHUA FRIEDMAN PHONE NO : 203-778-0200
43 MIRY BROOK RD. SE DECISION MADE: 23-JAN-09
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PM-1000F+PATIENT MONITOR
ADVANCED INSTRUMENTATIONS, INC. 510(k) NO: K082887(TRADITIONAL)
ATTN: JORGE MILLIAN PHONE NO : 305-925-1260
601 W 20 ST SE DECISION MADE: 16-JAN-09
HIALEAH, FL 33010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE
ADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K083915(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467
LN 999, ZHONGSHAN #2 RD (S) SE DECISION MADE: 29-JAN-09
SUITE 8D, NO. 19 510(k) STATEMENT
SHANGHAI, CHINA 20030 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO: METHA HIP SYSTEM
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K083495(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PWKY. SE DECISION MADE: 15-JAN-09
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLAZ
AESTHERA CORPORATION 510(k) NO: K083730(SPECIAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 925-980-7007
1070 CONCORD AVE SE DECISION MADE: 09-JAN-09
SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA
CONCORD, CA 94520
DEVICE: CALTRIX RESORBABLE BONE VOID FILLER
AG DIGITAL TECHNOLOGY CORP. 510(k) NO: K083279(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
2904 N. BOLDT DRIVE SE DECISION MADE: 28-JAN-09
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSTRIP OB
AIRSTRIP TECHNOLOGIES, LP 510(k) NO: K090061(TRADITIONAL)
ATTN: PHONE NO :
3303 OAKWELL CT., SUITE 200 SE DECISION MADE: 23-JAN-09
SAN ANTONIO, TX 78218 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: S-TEST C-REACTIVE PROTEIN (CRP)
ALFA WASSERMANN DIAGNOSTIC TECHNOL510(k) NO: K083040(TRADITIONAL)
ATTN: DENNIS TASCHEK PHONE NO : 973-852-0177
4 HENDERSON DRIVE SE DECISION MADE: 30-JAN-09
WEST CALDWELL, NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
ALLEZ SPINE, LLC 510(k) NO: K083826(SPECIAL)
ATTN: HARTMUT LOCH PHONE NO : 949-752-7885
2301 DUPONT DRIVE, SUITE 510 SE DECISION MADE: 22-JAN-09
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
ALMA LASERS LTD. 510(k) NO: K082622(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVE. SE DECISION MADE: 12-JAN-09
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENEGADE WHEELCHAIR
ALPHA ONE 510(k) NO: K082857(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVE SE DECISION MADE: 06-JAN-09
SUITE 509 510(k) SUMMARY AVAILABLE FROM FDA
CHEVY CHASE, MD 20815
DEVICE: CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS
ALTATEC GMBH 510(k) NO: K083496(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 30-JAN-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
AMNISURE INTERNATIONAL, LLC 510(k) NO: K081767(TRADITIONAL)
ATTN: MICHAEL FRIEDMAN PHONE NO : 617-234-4441
30 JFK STREET , 4TH FLOOR SE DECISION MADE: 09-JAN-09
CAMBRIDGE, MA 02138 510(k) STATEMENT
DEVICE: FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961
ANDON HEALTH CO.,LTD 510(k) NO: K083246(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 29-JAN-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300190
DEVICE: FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906
ANDON HEALTH CO.,LTD 510(k) NO: K083247(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 29-JAN-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300190
DEVICE: FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
ANDON HEALTH CO.,LTD 510(k) NO: K083248(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 29-JAN-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300190
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902
ANDON HEALTH CO.,LTD 510(k) NO: K083317(SPECIAL)
ATTN: LIU YI PHONE NO : 86 22 60526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 29-JAN-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904
ANDON HEALTH CO.,LTD 510(k) NO: K083318(SPECIAL)
ATTN: LIU YI PHONE NO : 86 22 60526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 29-JAN-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300190
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941
ANDON HEALTH CO.,LTD 510(k) NO: K083319(SPECIAL)
ATTN: LIU YI PHONE NO : 86 22 60526161
NO 31, CHANGJIANG ROAD SE DECISION MADE: 29-JAN-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300190
DEVICE: APIERON INSIGHT ENO SYSTEM
APIERON, INC. 510(k) NO: K083617(SPECIAL)
ATTN: NINA PELED PHONE NO : 650-454-0322
155 JEFFERSON DRIVE SE DECISION MADE: 27-JAN-09
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
APNEICARE, LLC 510(k) NO: K082968(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 02-JAN-09
BONITA SPRINGS, FL 34134-2958 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOLLO ANTERIOR CERVICAL PLATE SYSTEM
APOLLO SPINE, INC. 510(k) NO: K082504(TRADITIONAL)
ATTN: PAMELA PAPINEAU, RAC PHONE NO : 978-772-3552
307 PLACENTIA AVE. SE DECISION MADE: 27-JAN-09
SUITE 111 510(k) SUMMARY AVAILABLE FROM FDA
NEWPORT BEACH, CA 92663
DEVICE: ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSH
ARTHREX, INC. 510(k) NO: K082810(TRADITIONAL)
ATTN: NANCY HOFT PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 23-JAN-09
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
ARTHROCARE CORP. 510(k) NO: K083240(TRADITIONAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949-585-2406
15285 ALTON PARKWAY SE DECISION MADE: 12-JAN-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
ASAHI INTECC CO., LTD. 510(k) NO: K083145(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL AVE, SUITE 210 SE DECISION MADE: 12-JAN-09
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI SUOH PTCA GUIDE WIRE
ASAHI INTECC CO., LTD. 510(k) NO: K083904(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
2500 RED HILL SUITE 210 SE DECISION MADE: 29-JAN-09
SANTA ANA,, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION SILICONE PIP
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K082231(TRADITIONAL)
ATTN: DEBBIE STEARNS PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 12-JAN-09
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRIUM PROLITE S MESH
ATRIUM MEDICAL CORP. 510(k) NO: K082748(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 14-JAN-09
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: BIRTHTRACK (A.K.A. CLM)
BARNEV, LTD. 510(k) NO: K082704(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS ST. SE DECISION MADE: 09-JAN-09
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
BAUSCH & LOMB, INC. 510(k) NO: K082473(ABBREVIATED)
ATTN: NED L LUCE PHONE NO : 585-338-6368
1400 NORTH GOODMAN ST. SE DECISION MADE: 05-JAN-09
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALL-IN-ONE CONTAINER
BAXTER HEALTHCARE CORPORATION 510(k) NO: K090096(TRADITIONAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-270-4871
1620 WAUKEGAN ROAD SE DECISION MADE: 30-JAN-09
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BEAU RX SCAR CARE GEL
BEAU RX SOLUTIONS, LLC. 510(k) NO: K083718(TRADITIONAL)
ATTN: THOMAS L MCGRAW PHONE NO : 954-817-6155
1440 S. OCEAN BLVD. SE DECISION MADE: 26-JAN-09
SUITE 5C 510(k) SUMMARY AVAILABLE FROM FDA
LAUDERDALE BY THE SEA, FL 33062
DEVICE: COULTER LIN-X LINEARITY CONTROL
BECKMAN COULTER, INC. 510(k) NO: K081641(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305-380-4191
11800 SW 147TH AVE. SE DECISION MADE: 16-JAN-09
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER 6C CELL CONTROL, MODELS 628027 & A59925
BECKMAN COULTER, INC. 510(k) NO: K081822(TRADITIONAL)
ATTN: LOURDES COBA PHONE NO : 305-380-4079
11800 SW 147TH AVE. SE DECISION MADE: 21-JAN-09
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-1
BECTON, DICKINSON & CO. 510(k) NO: K082852(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 29-JAN-09
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SIGNS MONITOR, MODEL: MD500B
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K082787(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
#8D,ZHONGXIN ZHONGSHAN MANSION SE DECISION MADE: 12-JAN-09
NO.19,LANE 999,ZHONG SHAN NAN 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, SHANGHAI, CHINA 20020
DEVICE: LANDLEX, MODEL: 402X
BESTEAM TECHNOLOGY INC. 510(k) NO: K083303(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2 NO. 1 LANE 25 SE DECISION MADE: 26-JAN-09
ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: HEALTH MANAGER, VERSION 1.1
BIOCOMFORT DIAGNOSTICS GMBH & CO. 510(k) NO: K081499(TRADITIONAL)
ATTN: MARION OTTO PHONE NO : 49 715 8980160
BERNHAEUSER STRASSE 17 SE DECISION MADE: 16-JAN-09
NEUHAUSEN A.D.F., GERMANY 73765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND
BIOCOMPATIBLES, INC. 510(k) NO: K083274(TRADITIONAL)
ATTN: WAYNE RICHARDSON PHONE NO : 202-262-4190
115 HURLEY ROAD SE DECISION MADE: 08-JAN-09
OXFORD, CT 06474 510(k) STATEMENT
DEVICE: BIOLAND BLOOD PRESSURE MONITOR
BIOLAND TECHNOLOGY LTD. 510(k) NO: K083681(TRADITIONAL)
ATTN: DAVID LEE PHONE NO : 852 250 30868
BLK C, G/F, MING CT., SE DECISION MADE: 16-JAN-09
19-23 MING YUEN W. ST. 510(k) SUMMARY AVAILABLE FROM FDA
NORTH POINT, HONG KONG THIRD PARTY REVIEW
DEVICE: 180W CERELAS D 980NM DIODE LASER, MODEL D180
BIOLITEC, INC. 510(k) NO: K083682(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 09-JAN-09
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
BIOMERIX CORPORATION 510(k) NO: K082941(TRADITIONAL)
ATTN: CHRISTINA L KICHULA PHONE NO : 510-933-1222
47757 FREMONT BLVD SE DECISION MADE: 07-JAN-09
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX DELTA OPTION CERAMIC HEADS
BIOMET, INC. 510(k) NO: K082996(SPECIAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 15-JAN-09
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMLAB CRANIAL ORTHOSIS HELMET
BIOSCULPTOR CORPORATION 510(k) NO: K081787(TRADITIONAL)
ATTN: MARK MAZLOFF PHONE NO : 305-556-5815
2480 WEST 82ND STREET #8 SE DECISION MADE: 27-JAN-09
HIALEAH, FL 33016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
BIOSENSE WEBSTER, INC. 510(k) NO: K081258(TRADITIONAL)
ATTN: NATALIE BENNINGTON PHONE NO : 909-839-7272
3333 DIAMOND CANYON RD. SE DECISION MADE: 06-JAN-09
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRATEMP SOLUTION WARMER
C CHANGE SURGICAL LLC 510(k) NO: K083417(TRADITIONAL)
ATTN: PATRICK KAMMER PHONE NO : 336-723-0200
101 NORTH CHESTNUT STREET SE DECISION MADE: 13-JAN-09
SUITE 301 510(k) STATEMENT
WINSTON-SALEM, NC 27101
DEVICE: DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 011
C.R. BARD, INC. 510(k) NO: K082396(TRADITIONAL)
ATTN: STEPHANIE BAKER PHONE NO : 401-463-7000
100 CROSSINGS BOULEVARD SE DECISION MADE: 02-JAN-09
WARWICK, RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC
C.R. BARD, INC. 510(k) NO: K083839(SPECIAL)
ATTN: TERRI MORRIS PHONE NO : 678-342-4922
13183 HARLAND DRIVE SE DECISION MADE: 15-JAN-09
COVINGTON, GA 30014-6421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALHEALTH, INC., FINGER BLOOD PRESSURE MONITOR, MDMOUSE
CALHEALTH INC 510(k) NO: K081924(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO 58, FU-CHIN ST. SE DECISION MADE: 07-JAN-09
HSIN-CHU CITY, CHINA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
CARD GUARD SCIENTIFIC SURVIVAL, LT510(k) NO: K082521(TRADITIONAL)
ATTN: ALEX GONOROVSKY PHONE NO : 972 8 9484000
2 PEKERIS ST. SE DECISION MADE: 16-JAN-09
PO BOX 527 510(k) STATEMENT
REHOVOT, ISRAEL 76100
DEVICE: DUAL NEEDLE SUTURE PASSER SYSTEM
CAYENNE MEDICAL, INC. 510(k) NO: K082518(TRADITIONAL)
ATTN: KERESHMEH SHAHRIARI PHONE NO : 480-502-3661
16597 N. 92ND STREET SE DECISION MADE: 16-JAN-09
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85260
DEVICE: SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
CHEST M.I., INC. 510(k) NO: K080921(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 011 813 38188577
4-2-1 YUSHIMA, BUNKYO-KU SE DECISION MADE: 21-JAN-09
TOKYO, JAPAN 113-0034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
CLARITY MEDICAL SYSTEMS 510(k) NO: K083771(SPECIAL)
ATTN: GARY A SEEGER PHONE NO : 925-463-7984
5775 WEST LAS POSITAS BLVD. SE DECISION MADE: 30-JAN-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588-4084
DEVICE: CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
CLINIQA CORPORATION 510(k) NO: K081908(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
774 N. TWIN OAKS VALLEY RD. SE DECISION MADE: 16-JAN-09
SAN MARCOS, CA 92069 510(k) STATEMENT
DEVICE: CFS FLEXIBLE
COMFORT AND FLEXIBLE SYSTEMS 510(k) NO: K081537(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 22-JAN-09
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONFIDANT, MODEL 2.6
CONFIDANT INC. 510(k) NO: K083331(SPECIAL)
ATTN: DANIEL R PLONSKI PHONE NO : 919-806-4323
2530 MERIDIAN PARKWAY SE DECISION MADE: 09-JAN-09
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
DURHAM, NC 27713
DEVICE: OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
CORDIS CORP., A JOHNSON & JOHNSON 510(k) NO: K083814(TRADITIONAL)
ATTN: KAREN WILK PHONE NO : 908-412-7257
7 POWDER HORN DR. SE DECISION MADE: 13-JAN-09
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYNOSURE SMARTLIPO MPX LASER
CYNOSURE, INC. 510(k) NO: K083795(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 21-JAN-09
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOCALIS GEL
CYTOPHIL INC 510(k) NO: K081815(TRADITIONAL)
ATTN: GREG JOHNSON PHONE NO : 414-961-7372
5546 N SANTA MONICA BLVD SE DECISION MADE: 05-JAN-09
WHITEFISH BAY, WI 53217-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOCALIS AND VOCALIS SM
CYTOPHIL INC 510(k) NO: K081816(TRADITIONAL)
ATTN: GREG JOHNSON PHONE NO : 414-961-7372
5546 N SANTA MONICA BLVD SE DECISION MADE: 05-JAN-09
WHITEFISH BAY, WI 53217-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DO
DELTEX MEDICAL LIMITED 510(k) NO: K073593(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 441 763222505
BUSINESS & TECHNOLOGY CENTER/ SE DECISION MADE: 29-JAN-09
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE, HERTFORDSHIRE, UNITED KINGDOM SG1 2DX
DEVICE: CERCOM CEMENT
DENALI R&D CORPORATION 510(k) NO: K083398(TRADITIONAL)
ATTN: JAN G STANNARD PHONE NO : 781-826-9190
134 OLD WASHINGTON STREET SE DECISION MADE: 26-JAN-09
HANOVER, MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR BRAVO
DENALI R&D CORPORATION 510(k) NO: K083473(TRADITIONAL)
ATTN: JAN STANNARD PHONE NO : 781-826-9190
134 OLD WASHINGTON STREET SE DECISION MADE: 22-JAN-09
HANOVER, MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZMATCH BLOCK
DENTAIM CO., LTD. 510(k) NO: K083201(TRADITIONAL)
ATTN: DAESUCK CHUN PHONE NO : 82 221 096380
197-17, GURO-DONG, GURO-GU SE DECISION MADE: 26-JAN-09
SEOUL, REPUBLIC OF KOREA 152-848 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STER-MATE STERILE LAVAGE KIT
DENTSPLY INTERNTIONAL 510(k) NO: K082973(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-849-4229
221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 29-JAN-09
SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17405
DEVICE: MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K083258(TRADITIONAL)
ATTN: THERON GOBER PHONE NO : 770-514-6204
1155 ROBERTS BLVD. SE DECISION MADE: 30-JAN-09
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR SONIC SCALER
DPM USA CORP. 510(k) NO: K083059(TRADITIONAL)
ATTN: GEORGE ECHEVERRI PHONE NO : 305-640-9894
1460 NW 107 AVE. SUITE G SE DECISION MADE: 30-JAN-09
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
DUTCH OPHTHALMIC RESEARCH CENTER I510(k) NO: K081877(TRADITIONAL)
ATTN: GER VIJFVINKEL PHONE NO : 31 181 458080
SCHEIJDELVEG 2 SE DECISION MADE: 05-JAN-09
ZUIDLAND, NETHERLANDS 3214 VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX E
DYNAREX CORPORATION 510(k) NO: K082863(TRADITIONAL)
ATTN: JAMES HURLMAN PHONE NO : 845-365-8200
10 GLENSHAW ST. SE DECISION MADE: 09-JAN-09
ORANGEBURG, NY 10962 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO URESTA PESSARY
EASTMED INC. 510(k) NO: K083769(SPECIAL)
ATTN: ROSHANA AHMED PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 14-JAN-09
DUNDAS, ONTARIO, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPANDABLE PEEK-OPTIMA IMPLANT
EBI, L.P. 510(k) NO: K082406(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 14-JAN-09
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K083470(TRADITIONAL)
ATTN: ERICA WALTERS PHONE NO : 949-250-2438
ONE EDWARDS WAY SE DECISION MADE: 23-JAN-09
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR LCD MONITOR, RADIFORCE RX320
EIZO NANAO CORPORATION 510(k) NO: K090045(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 28-JAN-09
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLEX INNOVATIVE IMAGING EYE CUBED V4
ELLEX, INC. 510(k) NO: K083061(ABBREVIATED)
ATTN: TOM DAVIS PHONE NO : 800-765-7226
9940 BUSINESS PARK DR. SE DECISION MADE: 09-JAN-09
SUITE 165 510(k) STATEMENT
SACRAMENTO, CA 95827
DEVICE: SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-100
ENDOPHOTONIX, INC 510(k) NO: K082409(TRADITIONAL)
ATTN: KIRK S HONOUR PHONE NO : 651-452-3000
9725 SOUTH ROBERT TRAIL SE DECISION MADE: 21-JAN-09
INVER GROVE HEIGHTS, MN 55077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS
ENTRA HEALTH SYSTEMS, LTD. 510(k) NO: K081703(TRADITIONAL)
ATTN: CARLOS GONZALEZ PHONE NO : 925-484-4238
7833 KNOLLBROOK DRIVE SE DECISION MADE: 08-JAN-09
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENTACT SEPTAL STAPLER, MODEL 610-00100
ENTRIGUE SURGICAL, INC. 510(k) NO: K082750(TRADITIONAL)
ATTN: GABRIELE G NIEDERAUER PHONE NO : 210-298-6336
12672 SILICON DRIVE SE DECISION MADE: 06-JAN-09
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
SAN ANTONIO, TX 78249
DEVICE: EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
EPS BIO TECHNOLOGY CORP. 510(k) NO: K081796(TRADITIONAL)
ATTN: Y.C. LEI PHONE NO : 886 3 5752522
2 F,NO. 49-2, LANE 2, SEC. 2, SE DECISION MADE: 23-JAN-09
GUANG FU ROAD 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU CITY, CHINA (TAIWAN) 30071
DEVICE: EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008
EPS BIO TECHNOLOGY CORP. 510(k) NO: K083099(SPECIAL)
ATTN: Y. C LEI PHONE NO : 886 357 52522
2 F,NO. 49-2, LANE 2, SEC. 2, SE DECISION MADE: 16-JAN-09
GUANG FU ROAD 510(k) STATEMENT
HSINCHU CITY, CHINA (TAIWAN) 30071
DEVICE: MYLABFIVE
ESAOTE EUROPE B.V. 510(k) NO: K083882(TRADITIONAL)
ATTN: JAMIE AUSTIN PHONE NO : 317-569-9500
11460 N. MERIDIAN STREET SE DECISION MADE: 30-JAN-09
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
CARMEL, IN 46032 THIRD PARTY REVIEW
DEVICE: ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
ETHICON ENDO-SURGERY, INC. 510(k) NO: K082955(TRADITIONAL)
ATTN: GLENDA C MARSH PHONE NO : 513-337-7659
4545 CREEK RD. SE DECISION MADE: 15-JAN-09
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIFIT S, MODEL RS-LR1001004
EUMEDICS MEDIZINTECHNIK UND MARKET510(k) NO: K080299(TRADITIONAL)
ATTN: DAVID LEVINE PHONE NO : 773-517-9386
1341 W FULLERTON SE DECISION MADE: 13-JAN-09
SUITE 103 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60014
DEVICE: EXTREMITY MEDICAL SUTURE ANCHOR
EXTREMITY MEDICAL LLC 510(k) NO: K083151(TRADITIONAL)
ATTN: JAMY GANNOE PHONE NO : 973-588-8980
300 INTERPACE PARKWAY SE DECISION MADE: 22-JAN-09
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
PARSIPPANY, NJ 07054
DEVICE: A-LAP SET (A-LAP, EZAXESS, TROCAR)
EZSURGICAL 510(k) NO: K082291(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
5401 S. COTTONWOOD CT. SE DECISION MADE: 02-JAN-09
GREENWOOD VILLAGE, CO 80121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUBRICANO-ULTRASOUND
FARCO PHARMA GMBH 510(k) NO: K083358(TRADITIONAL)
ATTN: SETH A MAILHOT PHONE NO : 202-637-2309
555 ELEVENTH STREET NW SE DECISION MADE: 09-JAN-09
WASHINGTON, DC 20004-1304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K080964(SPECIAL)
ATTN: JANET C KAY PHONE NO : 781-699-4475
920 WINTER STREET SE DECISION MADE: 14-JAN-09
WALTHAM, MA 02451-1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIVISION SL SYSTEM
GEBAUER MEDIZINTECHNIK GMBH 510(k) NO: K072102(TRADITIONAL)
ATTN: KIMBERLEY DONEY PHONE NO : 781-860-0388
54 FOREST STREET SE DECISION MADE: 16-JAN-09
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME LP(A) ASSAY
GENERAL ATOMICS 510(k) NO: K082488(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858-455-4762
12889 GREGG COURT SE DECISION MADE: 13-JAN-09
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G1B PULSE OXIMETER
GENERAL MEDITECH, INC. 510(k) NO: K082789(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467
SUITE 8D, NO.19, LANE 999 SE DECISION MADE: 07-JAN-09
ZHONGSHAN NO. 2 ROAD (S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: PATIENT ISOLATION UNIT, MODEL G019-1000
GENTEX CORPORATION 510(k) NO: K080117(TRADITIONAL)
ATTN: BARRY SHOPE PHONE NO : 909-481-7667
11525 SIXTH ST. SE DECISION MADE: 30-JAN-09
RANCHO CUCAMONGA, CA 91730 510(k) STATEMENT
DEVICE: GISH ARTERIAL FILTER WITH HA COATING
GISH BIOMEDICAL, INC. 510(k) NO: K081054(TRADITIONAL)
ATTN: HARVEY KNAUSS PHONE NO : 713-723-4080
11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 15-JAN-09
HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
GISH BIOMEDICAL, INC. 510(k) NO: K081838(TRADITIONAL)
ATTN: MARTIN SELLERS PHONE NO : 949-635-6200
22942 ARROYO VISTA SE DECISION MADE: 26-JAN-09
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GISH TUBING AND CONNECTORS WITH HA COATING
GISH BIOMEDICAL, INC. 510(k) NO: K081881(TRADITIONAL)
ATTN: EDWARD F WADDELL PHONE NO : 949-635-6200
22942 ARROYO VISTA SE DECISION MADE: 23-JAN-09
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLVE STABILIZATION SYSTEM
GLOBUS MEDICAL, INC. 510(k) NO: K083416(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 09-JAN-09
VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
AUDUBON, PA 19403
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK
GX CORPORATION SDN BHD 510(k) NO: K083717(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 11600
LOT 6487A, BATU 5 3/4, SEMENTA SE DECISION MADE: 30-JAN-09
JALAN KAPAR 510(k) STATEMENT
KLANG, SELANG DARUL EHSAN, MALAYSIA 42100
DEVICE: IBOND TOTAL ETCH
HERAEUS KULZER GMBH 510(k) NO: K083652(TRADITIONAL)
ATTN: CHERYL ZIMMERMAN PHONE NO : 574-299-5444
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 21-JAN-09
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDEARE BREAST PUMP
HYGEIA MEDICAL, INC. 510(k) NO: K081932(TRADITIONAL)
ATTN: JASPER BENKE PHONE NO : 760-918-0339
6353 CORTE DEL ABETO SE DECISION MADE: 22-JAN-09
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: SPECTRA-SYSTEM ABUTMENTS 2008
IMPLANT DIRECT LLC 510(k) NO: K081101(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317
27030 MALIBU HILLS RD. SE DECISION MADE: 14-JAN-09
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWISSPLANT DENTAL IMPLANT SYSTEM
IMPLANT DIRECT LLC 510(k) NO: K081396(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317
27030 MALIBU HILLS RD. SE DECISION MADE: 14-JAN-09
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IROOT BP, MODEL IRBP 4609
INNOVATIVE BIOCERAMIX INC. 510(k) NO: K082943(TRADITIONAL)
ATTN: QUANZU YANG PHONE NO : 604 221 6800
1628 WEST 75TH AVE. SE DECISION MADE: 06-JAN-09
VANCOUVER, BC, CANADA V6P 6G2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IM
INSIGHTRA MEDICAL, INC. 510(k) NO: K082746(TRADITIONAL)
ATTN: TOM COLONNA PHONE NO : 949-215-1835
15560-C ROCKFIELD BLVD. SE DECISION MADE: 12-JAN-09
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
IVD RESEARCH, INC. 510(k) NO: K081064(TRADITIONAL)
ATTN: MICHAEL WIENHOLT PHONE NO : 928-863-2814
5470 E. EDWIN RD. SE DECISION MADE: 14-JAN-09
TUCSON, AZ 85739 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGESVR PACS
JAGUAR TECHNOLOGY LIMITED 510(k) NO: K082808(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO. 58, FU CHIUN STREET SE DECISION MADE: 09-JAN-09
HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.V. FISTULA BLUNT NEEDLE SET
JMS NORTH AMERICA CORP. 510(k) NO: K082882(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 704-516-8197
55 NORTHERN BLVD. , SUITE 200 SE DECISION MADE: 21-JAN-09
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEO-VAGINA SURGERY SET AND ACCESSORIES
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K071754(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 07-JAN-09
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANASIL INITIAL CONTACT AND PANASIL TRAY
KETTENBACH GMBH & CO KG 510(k) NO: K083701(SPECIAL)
ATTN: KRISTI KISTNER PHONE NO : 805-682-8685
975 VERONICA SPRINGS ROAD SE DECISION MADE: 09-JAN-09
SANTA BARBARA, CA 93105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE STORAGE SYSTEM, MODEL KSS-400
KONAN MEDICAL, INC. 510(k) NO: K081797(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 22-JAN-09
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO KOWA NONMYD ALPHA-DIII
KOWA CO. LTD. 510(k) NO: K083387(SPECIAL)
ATTN: AKIHIRO FUJITA PHONE NO : 81 035 6238049
4-14, NIHONBASHI-HONCHO SE DECISION MADE: 16-JAN-09
3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA
CHUO-KU, TOKYO, JAPAN 103-8433
DEVICE: KUBTEC XPERT 20
KUB TECHNOLOGIES, INC 510(k) NO: K083510(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-922-0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 08-JAN-09
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM
LEMAITRE VASCULAR, INC. 510(k) NO: K081878(TRADITIONAL)
ATTN: ERIN DALY PHONE NO : 781-221-2266
63 SECOND AVENUE SE DECISION MADE: 27-JAN-09
BURLINGTON, MA 01803 510(k) STATEMENT
DEVICE: NEPTUNE HYPERBARIC VENTILATOR
LEVEL-5, INC. 510(k) NO: K082351(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST., NW SE DECISION MADE: 02-JAN-09
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
LEVITRONIX LLC. 510(k) NO: K090004(SPECIAL)
ATTN: SUSAN HAMANN PHONE NO : 781-466-6553
45 FIRST AVE. SE DECISION MADE: 15-JAN-09
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILOT SPINAL SYSTEM
LIFE SPINE 510(k) NO: K083865(SPECIAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117
2401 W. HASSELL RD. SE DECISION MADE: 28-JAN-09
SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60169
DEVICE: MAICO MB 11 WITH BERAPHONE PROBE
MAICO DIAGNOSTICS 510(k) NO: K082035(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4157
7625 GOLDEN TRIANGLE DR. SE DECISION MADE: 29-JAN-09
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: SYRINGE WITH HANDI-FIL
MALLINCKRODT INC., LIEBEL-FLARSHEI510(k) NO: K082212(SPECIAL)
ATTN: DALE MOORE PHONE NO : 513-948-5771
2111 EAST GALBRAITH RD. SE DECISION MADE: 22-JAN-09
CINCINNATI, OH 45237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
MAXIM HYGIENE PRODUCTS, INC. 510(k) NO: K090098(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
1468 HARWELL AVE. SE DECISION MADE: 30-JAN-09
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMNS MEDACTA NAVIGATION SYSTEM
MEDACTA INTERNATIONAL, SA 510(k) NO: K083872(TRADITIONAL)
ATTN: NATLIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 15-JAN-09
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDIGARD BLOOD COLLECTION DEVICE
MEDIGARD LIMITED 510(k) NO: K082511(TRADITIONAL)
ATTN: EJ SMITH PHONE NO : 888-729-9674
1468 HARWELL AVE SE DECISION MADE: 16-JAN-09
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDINOL X-SUIT NIR BILIARY METALLIC STENT
MEDINOL LTD. 510(k) NO: K081956(TRADITIONAL)
ATTN: LEO L BASTA PHONE NO : 508-351-8632
386 WEST MAIN STREET SE DECISION MADE: 09-JAN-09
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
NORTHBORO, MA 01532
DEVICE: MEDISIZE BLUE, MEDISIZE GREEN, MEDISIZE RED
MEDISIZE BV 510(k) NO: K081536(TRADITIONAL)
ATTN: PHONE NO :
EDISONSTRAAT 1 SE DECISION MADE: 23-JAN-09
HILLEGOM, NETHERLANDS 2181 AB 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC
MEDRAD, INC. 510(k) NO: K082905(TRADITIONAL)
ATTN: FORTUNATO ALDAPE PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 12-JAN-09
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERGRAFT RESORBABLE CERAMIC GRANULES
MEDTRONIC SOFAMOR DANEK 510(k) NO: K082917(TRADITIONAL)
ATTN: RYAN MASSEY PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 09-JAN-09
MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTE
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K082728(TRADITIONAL)
ATTN: MELISA LANSKY PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 16-JAN-09
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
MEDWAVES INCORPORATED 510(k) NO: K083537(SPECIAL)
ATTN: TED ORMSBY PHONE NO : 858-531-3326
16760 WEST BERNARDO DRIVE SE DECISION MADE: 15-JAN-09
SAN DIEGO, CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEL SPINAL SYSTEM
MEDYSSEY CO., LTD. 510(k) NO: K081153(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 30-JAN-09
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: PREMIER CAMPY, MODEL 618096
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K083464(TRADITIONAL)
ATTN: SUSAN D ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 30-JAN-09
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOLI SYSTEM, "DELTAPLUSH", MODELS CPL, DPL
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K083646(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 02-JAN-09
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIROXI
MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K081033(TRADITIONAL)
ATTN: SIMON FOWLER PHONE NO : 39 062 2754777
VIA DEL MAGGIOLINO 125 SE DECISION MADE: 15-JAN-09
ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPER
MOOR INSTRUMENTS LTD. 510(k) NO: K083082(TRADITIONAL)
ATTN: XIABING HUANG PHONE NO : 441 297 35715
MILLWEY SE DECISION MADE: 13-JAN-09
AXMINSTER, DEVON, UNITED KINGDOM E510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
MRI CARDIAC SERVICES, INCORPORATED510(k) NO: K082526(TRADITIONAL)
ATTN: SCOTT HUBER PHONE NO : 336-831-1908
8 WEST THIRD ST. SUITE M9 SE DECISION MADE: 05-JAN-09
WINSTON-SALEM, NC 27101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARE3 PLUS
NAKANISHI, INC. 510(k) NO: K081811(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SE DECISION MADE: 21-JAN-09
SUITE 1100 510(k) STATEMENT
WASHINGTON, DC 20005
DEVICE: REAL-TIME PCR INTERNAL CONTROL 2B SET
NANOGEN, INC. 510(k) NO: K083430(TRADITIONAL)
ATTN: E. JOSEPH MCMULLEN PHONE NO : 858-410-4600
10398 PACIFIC CENTER CT. SE DECISION MADE: 15-JAN-09
SAN DIEGO, CA 92121-4340 510(k) STATEMENT
DEVICE: MD21M 21.3" DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K083332(TRADITIONAL)
ATTN: ANGUS HSU PHONE NO : 886 2 26037288
1F, NO. 181, SEC. 2 WUNHUA SE DECISION MADE: 09-JAN-09
1ST ROAD, LINKOU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPE, CHINA (TAIWAN) 244
DEVICE: MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K083907(TRADITIONAL)
ATTN: ANGUS HSU PHONE NO : 886 226 037288
1F, NO. 181, SEC. 2 WUNHUA SE DECISION MADE: 13-JAN-09
1ST ROAD, LINKOU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPE, CHINA (TAIWAN) 244 THIRD PARTY REVIEW
DEVICE: LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR,
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K083916(TRADITIONAL)
ATTN: ANGUS HSU PHONE NO : 886 2 26037288
1F, # 181, S. 2, WUNHUA 1ST RD SE DECISION MADE: 14-JAN-09
LINKOU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 24447 THIRD PARTY REVIEW
DEVICE: SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE
NEOCHILD, LLC 510(k) NO: K082710(TRADITIONAL)
ATTN: RHETT BOLEN PHONE NO : 888-887-6428
4605 N/ STILES SE DECISION MADE: 23-JAN-09
OKLAHOMA CITY, OK 73105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL ELECTRODES
NEUROMETRIX, INC. 510(k) NO: K083818(SPECIAL)
ATTN: RAINER MAAS PHONE NO : 781-890-9989
62 FOURTH AVE. SE DECISION MADE: 21-JAN-09
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLYING DIAGNOSTIC ULTRASOUND SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K083877(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 13-JAN-09
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: NORAS CPC MULTIFUNCTIONAL COIL
NORAS MRI PRODUCTS GMBH 510(k) NO: K083578(ABBREVIATED)
ATTN: ZAHED SEDIGHIANI PHONE NO : 49 931 2992717
LEIBNITZSTRASSE 4 SE DECISION MADE: 16-JAN-09
HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SURGICAL MESH SYSTEM
NUVASIVE, INC. 510(k) NO: K081377(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
7475 LUSK BLVD SE DECISION MADE: 15-JAN-09
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVO VERDE LED LIGHTING SYSTEM
NUVO, INC. 510(k) NO: K083323(ABBREVIATED)
ATTN: CURT V SCHAAFF PHONE NO : 814-899-4220
5368 KUHL RD. SE DECISION MADE: 28-JAN-09
ERIE, PA 16407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD CAMERA HEAD OTV-S7PROH-HD-L08E
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K083155(TRADITIONAL)
ATTN: STACY A KLUESNER PHONE NO : 484-896-5405
3500 CORPORATE PARKWAY SE DECISION MADE: 13-JAN-09
CENTER VALLEY, PA 18034-0610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP,
ONCOLOG MEDICAL QA AB 510(k) NO: K090044(TRADITIONAL)
ATTN: JAN TORNQVIST PHONE NO : 011 461 8194565
VALLVAGEN 4B SE DECISION MADE: 22-JAN-09
UPPSALA, SWEDEN 75651 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
ORTHOPEDIATRICS, CORP. 510(k) NO: K083286(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379
210 N. BUFFALO ST. SE DECISION MADE: 30-JAN-09
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIN VISION, MODEL PS-2100
OSACHI CO., LTD. 510(k) NO: K072882(TRADITIONAL)
ATTN: JAMES R GREENWOOD PHONE NO : 702-450-0425
3027 E. SUNSET RD., SUITE 105 SE DECISION MADE: 08-JAN-09
LAS VEGAS, NV 89120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACS SCAN
PACSGEAR, INC. 510(k) NO: K083618(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512-327-9997
1705 S. CAPITOL OF TEXAS HWY. SE DECISION MADE: 28-JAN-09
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: ULTIMA FIVE
PAIN MANAGEMENT TECHNOLOGIES 510(k) NO: K083494(TRADITIONAL)
ATTN: JOSHUA LEFKOVITZ PHONE NO : 800-239-7880
1340 HOME AVE. , BLDG A SE DECISION MADE: 06-JAN-09
AKRON, OH 44310 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, B
PANTHERA PRODUCTION AB 510(k) NO: K083231(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 26-JAN-09
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: HDS HI 1.54
PARAGON VISION SCIENCES 510(k) NO: K082799(TRADITIONAL)
ATTN: WILLIAM MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 27-JAN-09
MESA, AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASTURE, MODELS: F550, A520
PASTURE PHARMA PTE LTD 510(k) NO: K083176(TRADITIONAL)
ATTN: SARAH HASSAN PHONE NO : 860-371-5604
29266 VIA FRONTERA SE DECISION MADE: 23-JAN-09
MURRIETA, CA 92563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K083489(TRADITIONAL)
ATTN: BRIAN CLEARY PHONE NO : 425-636-4079
10801 120TH AVENUE NE SE DECISION MADE: 23-JAN-09
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND C
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K083837(SPECIAL)
ATTN: BRIAN CLEARY PHONE NO : 425-636-4079
10801 120TH AVENUE NE SE DECISION MADE: 13-JAN-09
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRGENT, MODEL AG7000010
PERFACTION, INC. 510(k) NO: K082138(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 23-JAN-09
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, M
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K083517(SPECIAL)
ATTN: ANDREAS SUCHI PHONE NO : 497 031 4631291
HEWLETT-PACKARD STR.2 SE DECISION MADE: 16-JAN-09
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNILUX CLEAR-U
PHOTO THERAPEUTICS, INC. 510(k) NO: K081307(TRADITIONAL)
ATTN: SUE DARCY PHONE NO : 760-607-0488
2720 LOKER AVENUE WEST SE DECISION MADE: 16-JAN-09
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSTORSOL
PRESERVATION SOLUTIONS, INC. 510(k) NO: K083453(TRADITIONAL)
ATTN: NEIL BURRIS PHONE NO : 720-323-1662
4250 GROVE STREET SE DECISION MADE: 21-JAN-09
DENVER, CO 80211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRUMYX CREAM
PRUGEN, INC. 510(k) NO: K082089(TRADITIONAL)
ATTN: ROBERT L KNECHTEL PHONE NO : 312-372-7664
10 SOUTH LASALLE STREET SE DECISION MADE: 13-JAN-09
SUITE 3300 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60603
DEVICE: RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MOD
QUANTRX BIOMEDICAL CORPORATION 510(k) NO: K080431(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 08-JAN-09
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYAUTOPLAN 1.0
RAYSEARCH LABORATORIES AB 510(k) NO: K083264(TRADITIONAL)
ATTN: ANDERS MURMAN PHONE NO : 46 8 54506157
SVEAVAGEN 25, PLAN 9 SE DECISION MADE: 22-JAN-09
STOCKHOLM, SWEDEN SE-111 34 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET,
RELIEVANT MEDSYSTEMS, INC. 510(k) NO: K083856(SPECIAL)
ATTN: MARK SMUTKA PHONE NO : 510-489-1080
713 SANDOVAL WAY SE DECISION MADE: 22-JAN-09
HAYWARD, CA 94544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPAP AUTO WITH HUMIDAIRE 3I
RESMED LTD. 510(k) NO: K082605(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 13-JAN-09
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S8 ADVANCE
RESMED LTD. 510(k) NO: K082979(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 02-JAN-09
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESSCAN-PRO
RESMED LTD. 510(k) NO: K082983(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 02-JAN-09
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V60 VENTILATOR, MODEL V8000
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K082660(TRADITIONAL)
ATTN: MARA CALER PHONE NO : 760-918-7458
2271 COSMOS CT. SE DECISION MADE: 09-JAN-09
CARLSBAD, CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOLUTIONFULL FACE MASK
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K082866(TRADITIONAL)
ATTN: ANDREW ZELTWANGER PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 30-JAN-09
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GALAXY
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K083874(TRADITIONAL)
ATTN: ANDREW P ZELTWANGER PHONE NO : 724-387-7442
1001 MURRY RIDGE LN. SE DECISION MADE: 26-JAN-09
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO ZENIEVA
RIVER'S EDGE PHARMACEUTICALS, LLC 510(k) NO: K083721(SPECIAL)
ATTN: SANDRA R KIRCUS PHONE NO : 919-281-4080
2445 SOUTH ALSTON AVE. SE DECISION MADE: 08-JAN-09
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA 400/800 BILIRUBIN TOTAL
ROCHE DIAGNOSTICS 510(k) NO: K081193(SPECIAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317-521-4569
9115 HAGUE RD. SE DECISION MADE: 16-JAN-09
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARVEL PEDIATRIC WHEELCHAIR
ROGUE WHEELCHAIRS INC 510(k) NO: K083847(TRADITIONAL)
ATTN: KATHRYN RONALDS PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 30-JAN-09
DUNDAS, ONTARIO, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
S & C POLYMER GMBH 510(k) NO: K082115(TRADITIONAL)
ATTN: CHRISTIAN BOETTCHER PHONE NO : 004 941 214830
ROBERT-BOSCH-STRASSE 5 SE DECISION MADE: 15-JAN-09
ELMSHORN, GERMANY D-25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NASO-LARYNGO-PHARYNGOSCOPE
SCHOELLY IMAGING, INC. 510(k) NO: K083553(SPECIAL)
ATTN: F. DAVID ROTHKOPF PHONE NO : 508-231-8842
200 HOMER AVENUE SE DECISION MADE: 16-JAN-09
ASHLAND, MA 01721 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTERIOR BUTTRESS PLATE
SCIENT'X USA, INC. 510(k) NO: K081548(TRADITIONAL)
ATTN: JOHN SANDERS PHONE NO : 407-571-2550
1015 MAITLAND CENTER COMMONS SE DECISION MADE: 29-JAN-09
SUITE 106A 510(k) SUMMARY AVAILABLE FROM FDA
MAITLAND, FL 32751
DEVICE: NEWPORT SPINAL SYSTEM
SEASPINE, INC. 510(k) NO: K083089(TRADITIONAL)
ATTN: ETHEL BERNAL PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 13-JAN-09
VISTA, CA 92081-7862 510(k) STATEMENT
DEVICE: NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
SIAM SEMPERMED CORP. LTD. 510(k) NO: K081911(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 15-JAN-09
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083159(TRADITIONAL)
ATTN: JANET M FOSE PHONE NO : 302-631-8826
500 GBC DRIVE M/S 514 SE DECISION MADE: 26-JAN-09
PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1,
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083175(TRADITIONAL)
ATTN: JANET M FOSE PHONE NO : 302-631-8826
500 GBC DRIVE M/S 514 SE DECISION MADE: 26-JAN-09
PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K081895(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443
511 BENEDICT AVENUE SE DECISION MADE: 08-JAN-09
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K083149(TRADITIONAL)
ATTN: PHONE NO :
1230 SHOREBIRD WAY SE DECISION MADE: 14-JAN-09
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SPECIALTY COILS FOR THE MAGNETOM ESSENZA
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K083166(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-448-3393
51 VALLEY STREAM PKWY. SE DECISION MADE: 13-JAN-09
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW PEEK INTERFERENCE SCREW
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K083226(TRADITIONAL)
ATTN: KATHY REDDIG PHONE NO : 978-749-1321
150 MINUTEMAN ROAD SE DECISION MADE: 30-JAN-09
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K083635(TRADITIONAL)
ATTN: CHRISTINA FLORES PHONE NO : 508-261-3705
150 MINUTEMAN ROAD SE DECISION MADE: 30-JAN-09
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERI-LOC BONE PLATING AND SCREW SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K083032(TRADITIONAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 07-JAN-09
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
SMITH & NEPHEW, INC. 510(k) NO: K083528(TRADITIONAL)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1980 NONCONNAH BLVD SE DECISION MADE: 28-JAN-09
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONY UP-DF750 DIGITAL FILM IMAGER
SONY ELECTRONICS, INC. 510(k) NO: K083522(TRADITIONAL)
ATTN: CYNTHIA SINCLAIR PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 09-JAN-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRYLIC HERBST SPLINT APPLIANCE
SPECIALTY APPLIANCE WORKS, INC. 510(k) NO: K083209(ABBREVIATED)
ATTN: CAROLYN THOMAS PHONE NO : 678-513-4408
4905 HAMMOND INDUSTRIAL DRIVE SE DECISION MADE: 27-JAN-09
CUMMING, GA 30041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHENIX CERVICAL INTERBODY DEVICE
SPINAL DEVICES, LLC 510(k) NO: K083167(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999
13540 GUILD AVE SE DECISION MADE: 13-JAN-09
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY SPINAL SYSTEM
SPINAL ELEMENTS, INC. 510(k) NO: K082353(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 22-JAN-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSURE PS SYSTEM
SPINE WAVE, INC. 510(k) NO: K083743(SPECIAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 13-JAN-09
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: REFLEXION HD HIGH-DENSITY MAPPING CATHETER
ST. JUDE MEDICAL 510(k) NO: K080179(TRADITIONAL)
ATTN: ANDREA HUDACK PHONE NO : 952-933-1627
14901 DEVEAU PL. SE DECISION MADE: 07-JAN-09
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SJM TAILOR ADJUSTABLE ANNULOPLASTY RING
ST. JUDE MEDICAL 510(k) NO: K083835(SPECIAL)
ATTN: WILLIAM MCKELVEY PHONE NO : 651-756-6574
177 EAST COUNTY ROAD B SE DECISION MADE: 23-JAN-09
ST. PAUL, MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED HARMONIC SCALPEL
STERILMED, INC. 510(k) NO: K083060(TRADITIONAL)
ATTN: DENNIS TOUSSAINT PHONE NO : 763-488-3410
11140 73RD AVE. NORTH SE DECISION MADE: 09-JAN-09
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK
STERIS CORPORATION 510(k) NO: K073618(TRADITIONAL)
ATTN: JOHN R SCOVILLE PHONE NO : 440-392-7330
5960 HEISLEY RD. SE DECISION MADE: 07-JAN-09
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STINGRAY ELECTROSURGICAL FORCEPS
STINGRAY SURGICAL PRODUCTS, INC 510(k) NO: K083162(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 12-JAN-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PITT-EASY DENTAL IMPLANT SYSTEM
SYBRON IMPLANT SOLUTIONS GMBH 510(k) NO: K083297(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602
1717 WEST COLLINS AVE. SE DECISION MADE: 28-JAN-09
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
SYNTHES (USA) 510(k) NO: K083025(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY. SE DECISION MADE: 14-JAN-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITI-S ESOPHAGEAL STENT
TAEWOONG MEDICAL CO., LTD 510(k) NO: K080782(ABBREVIATED)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 30-JAN-09
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONIT
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K082482(SPECIAL)
ATTN: SOPHIE LIN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 30-JAN-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: FORA TELEHEALTH SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K083046(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 16-JAN-09
WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K083664(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 09-JAN-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
TANGSHAN ZHONGHONG PULIN GROUP CO.510(k) NO: K082598(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG 1, JIANXIANG SE DECISION MADE: 07-JAN-09
YUAN NO. 209 BEI SI HUAN ZHO 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
TERANG NUSA SDN BHD 510(k) NO: K083337(SPECIAL)
ATTN: ROBERT HILL PHONE NO : 012 988 7001
1, JALAN 8, SE DECISION MADE: 27-JAN-09
PENGKALAN CHEPA 2 IND. ZONE 510(k) STATEMENT
KOTA BHARU, KELANTAN, MALAYSIA 16100
DEVICE: VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MO
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K083194(TRADITIONAL)
ATTN: JUNKO KUROSAWA PHONE NO : 734-663-4145
6200 JACKSON RD. SE DECISION MADE: 16-JAN-09
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THD SLIDE ONE
THD SPA 510(k) NO: K090009(SPECIAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LN. SE DECISION MADE: 28-JAN-09
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
THEKEN SPINE LLC 510(k) NO: K082712(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8609
1800 TRIPLETT BLVD. SE DECISION MADE: 02-JAN-09
AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTRO
THERMO FISHER SCIENTIFIC 510(k) NO: K081378(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
46360 FREMONT BLVD. SE DECISION MADE: 14-JAN-09
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASU
TOPCON MEDICAL SYSTEMS, INC. 510(k) NO: K072971(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 13-JAN-09
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS HUMERAL NAIL SYSTEM
TORNIER 510(k) NO: K082754(TRADITIONAL)
ATTN: BRIAN HODOREK PHONE NO : 574-268-0861
100 CAPITAL DRIVE SE DECISION MADE: 27-JAN-09
SUITE 201 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46582
DEVICE: PRO-TECH DELIVERY SYSTEM ELECTRODES, MODEL TT-2000
TRANSFER TECHNOLOGY 510(k) NO: K081279(TRADITIONAL)
ATTN: JOSEPH J ARBOUR PHONE NO : 951-677-0631
37822 OXFORD DRIVE SE DECISION MADE: 23-JAN-09
MURRIETA, CA 92562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUSON INTRAMEDULLARY NAIL
TRAUSON (JIANGSU) MEDICAL INSTRUME510(k) NO: K081230(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
LANE 999, ZHONGSHAN NO. 2 ROAD SE DECISION MADE: 13-JAN-09
SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: TRAUSON GENERAL SPINAL SYSTEM (GSS)
TRAUSON (JIANGSU) MEDICAL INSTRUME510(k) NO: K082617(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
LANE 999, ZHONGSHAN NO. 2 ROAD SE DECISION MADE: 15-JAN-09
SUITE 8D, NO. 19 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: VALO, MODEL 5919
ULTRADENT PRODUCTS, INC. 510(k) NO: K083647(SPECIAL)
ATTN: DIANE ROGERS PHONE NO : 801-553-4491
505 WEST 10200 SOUTH SE DECISION MADE: 23-JAN-09
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
VASCULAR SOLUTIONS, INC. 510(k) NO: K081846(TRADITIONAL)
ATTN: CHARMAINE SUTTON PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 28-JAN-09
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINNIE SUPPORT CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K082337(TRADITIONAL)
ATTN: CHARMAINE SUTTON PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 15-JAN-09
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XYCOR SPINAL IMPLANT
VERTEBRATION,INC 510(k) NO: K082466(TRADITIONAL)
ATTN: BARBARA FANT PHONE NO : 513-961-8200
310 TERRACE AVENUE, SUITE 201 SE DECISION MADE: 09-JAN-09
CINCINNATI, OH 45220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADPRO ION
VIRTUAL IMAGING, INC. 510(k) NO: K083725(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 22-JAN-09
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOCO PROFLUORID L
VOCO GMBH 510(k) NO: K083036(TRADITIONAL)
ATTN: M. PLAUMANN PHONE NO : 49 047 217190
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 12-JAN-09
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B A
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K090023(SPECIAL)
ATTN: JENNY HSIEH PHONE NO : 886 229 282112
1FL, NO.16, LANE 454 SE DECISION MADE: 30-JAN-09
JUNGJENG RD. 510(k) SUMMARY AVAILABLE FROM FDA
YUNGHE CITY, TAIPEI COUNTY, CHINA (TAIWAN)
DEVICE: PAM 3000
WIRELESS 2000 RF & UWB TECHNOLOGIE510(k) NO: K082626(TRADITIONAL)
ATTN: EFRAIM GAVRILOVICH PHONE NO : 604 298 8471
2421 ALPHA AVE SE DECISION MADE: 16-JAN-09
BURNABY, BC, CANADA V5C5L2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314
WONJIN MULSAN CO., LTD. 510(k) NO: K080134(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 562-943-4262
155 FLEMINGTON COURT SE DECISION MADE: 23-JAN-09
LA MIRADA, CA 90638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-FORCE TENODESIS SCREW
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K083150(TRADITIONAL)
ATTN: KELLEN HILLS PHONE NO : 901-290-5816
5677 AIRLINE RD. SE DECISION MADE: 15-JAN-09
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO LITONG PLASTIC PRODUCTS CO., 510(k) NO: K082936(TRADITIONAL)
ATTN: JOHN ZHAO PHONE NO : 909-548-4828
12390 EAST END AVE. SE DECISION MADE: 12-JAN-09
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 225
TOTAL WITH SUMMARIES 200
TOTAL WITH STATEMENTS 25
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