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Medical Devices
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April 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-APR-2009 THROUGH 30-APR-2009
DEVICE: P.D SOFTWARE
.DECIMAL, INC. 510(k) NO: K083672(TRADITIONAL)
ATTN: DANIEL BENNETT PHONE NO : 407-330-3300
121 CENTRAL PARK PLACE SE DECISION MADE: 13-APR-09
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH
3M COMPANY 510(k) NO: K090519(SPECIAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326
3M CENTER, BLDG. 260-2A-17 SE DECISION MADE: 15-APR-09
ST PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE
3M COMPANY 510(k) NO: K090569(SPECIAL)
ATTN: BRYAN BECKER PHONE NO : 651-733-3373
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 29-APR-09
ST. PAUL, MN 55133-3275 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BONOS INJECT
AAP BIOMATERIALS GMBH 510(k) NO: K090460(ABBREVIATED)
ATTN: VOLKER STIRNAL PHONE NO : 49 607 1929220
LAGERSTRASSE 11-15 SE DECISION MADE: 14-APR-09
DIEBURG, GERMANY D-64807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50,
ABBOTT DIABETES CARE INC. 510(k) NO: K083223(SPECIAL)
ATTN: ARUL STERLIN PHONE NO : 510-864-4310
1360 SOUTH LOOP RD. SE DECISION MADE: 16-APR-09
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREATININE
ABBOTT LABORATORIES 510(k) NO: K083809(SPECIAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1921 HURD DR. SE DECISION MADE: 07-APR-09
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPELLA 5.0 CATHETER FAMILY
ABIOMED, INC. 510(k) NO: K083111(TRADITIONAL)
ATTN: WILLIAM BOLT PHONE NO : 978-646-1451
22 CHERRY HILL DR. SE DECISION MADE: 16-APR-09
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AUTOFUSER
ACE MEDICAL US, LLC 510(k) NO: K090300(SPECIAL)
ATTN: ANDREW LAMBORNE PHONE NO : 303-957-8512
9102 TURFWAY BEND DR. SE DECISION MADE: 30-APR-09
POWELL, OH 43065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM
ACON LABORATORIES CO. 510(k) NO: K090057(TRADITIONAL)
ATTN: RICHARD LENART PHONE NO : 858-875-8019
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 08-APR-09
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER F
ACTHERM, INC. 510(k) NO: K090031(TRADITIONAL)
ATTN: RICHARD HSIEH PHONE NO : 886 3 6669596
6F, NO.18 JHANYE 2ND RD., SE DECISION MADE: 16-APR-09
HSINCHU SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU, CHINA (TAIWAN) 30078
DEVICE: INFANT CARDIAC ARRAY
ADVANCED IMAGING RESEARCH, INC. 510(k) NO: K083539(TRADITIONAL)
ATTN: RAVI SRINIVASAN PHONE NO : 216-426-4161
4700 LAKESIDE AVE. SE DECISION MADE: 03-APR-09
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
CLEVELAND, OH 44114
DEVICE: BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
AESCULAP IMPLANT SYSTEMS 510(k) NO: K090299(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PWKY. SE DECISION MADE: 24-APR-09
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: S4 SPINAL SYSTEM
AESCULAP IMPLANT SYSTEMS 510(k) NO: K090657(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 800-234-9179
3773 CORPORATE PWKY. SE DECISION MADE: 20-APR-09
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILECARE MONITOR, MODEL 2100
AFRAME DIGITAL, INC. 510(k) NO: K090138(TRADITIONAL)
ATTN: DARREN REEVES PHONE NO : 804-307-7706
15637 FOX COVE CIRCLE SE DECISION MADE: 24-APR-09
MOSELEY, VA 23120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALCO TUBE PLUS
ALCOTEST QUEBEC 510(k) NO: K082080(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
1468 HARWELL AVE SE DECISION MADE: 01-APR-09
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
ALMA LASERS LTD. 510(k) NO: K083848(TRADITIONAL)
ATTN: TATIANA EPSTEIN PHONE NO : 011 972 46275357
HALAMISH ST. POB 3021 SE DECISION MADE: 14-APR-09
INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CAESAREA, ISRAEL 38900
DEVICE: ROC LUMBAR PLATING SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K090228(TRADITIONAL)
ATTN: KARLA SCHAFFNER PHONE NO : 760-494-6739
5818 EL CAMINO REAL SE DECISION MADE: 29-APR-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVEL ALIF SPINAL SPACER SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K090782(SPECIAL)
ATTN: MARY STANNERS PHONE NO : 760-494-6771
5818 EL CAMINO REAL SE DECISION MADE: 22-APR-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090
AMERICAN BIOLOGICAL TECHNOLOGIES, 510(k) NO: K090854(TRADITIONAL)
ATTN: JOHN GROMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 16-APR-09
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAP WOUND DRESSING GEL
AMERICAN BIOTECH LABS 510(k) NO: K082333(TRADITIONAL)
ATTN: JAMES S TURNER PHONE NO : 202-462-8800
1400 16TH STREET NW SE DECISION MADE: 02-APR-09
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K090663(SPECIAL)
ATTN: STEPHANIE GEORGE PHONE NO : 952-930-6389
10700 BREN RD., WEST SE DECISION MADE: 09-APR-09
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APIC
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K090713(SPECIAL)
ATTN: DENISE THOMPSON PHONE NO : 952-930-6000
10700 BREN RD., WEST SE DECISION MADE: 02-APR-09
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
APEX BIOTECHNOLOGY CORP. 510(k) NO: K090043(SPECIAL)
ATTN: THOMAS Y.S. SHEN PHONE NO : 886 356 41952
NO. 7, LI-HSIN ROAD V, SE DECISION MADE: 09-APR-09
HSINCHU SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU, CHINA (TAIWAN) 30078
DEVICE: APEX MEDICAL XT AUTO CPAP 9S-005200
APEX MEDICAL CORP. 510(k) NO: K083656(TRADITIONAL)
ATTN: ALAN CHANG PHONE NO : 886 222 683100
NO. 9, MINSHENG STREET SE DECISION MADE: 22-APR-09
TUCHENG CITY, TAIPEI COUNTY, CHINA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEXUM ABLATOR
APEXUM LTD. 510(k) NO: K082325(TRADITIONAL)
ATTN: IDAN TOBIS PHONE NO : 972 363 49990
6 YONI NETANYAHU ST. SE DECISION MADE: 21-APR-09
OR-YEHUDA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APK SPO2 PULSE OXIMETER SENSOR
APK TECHNOLOGY CO., LTD 510(k) NO: K082846(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D, NO19, ZHONGSHAN SE DECISION MADE: 03-APR-09
MANSION, LANE 999, ZHONGSHAN 510(k) SUMMARY AVAILABLE FROM FDA
NO. 2 ROAD(S); SHANGHAI, CHINA 200030
DEVICE: AVC A/H5N1 FLU TEST
ARBOR VITA CORPORTATION 510(k) NO: K083278(TRADITIONAL)
ATTN: LINDA ALLISTER PHONE NO : 408-585-3909
772 LUCERNE DRIVE SE DECISION MADE: 08-APR-09
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMERSION HYDROBATH
ARJO HOSPITAL EQUIPMENT AB 510(k) NO: K082951(TRADITIONAL)
ATTN: TRACI GIOVENCO PHONE NO : 630-307-6140
50 NORTH GARY AVENUE, SUITE A SE DECISION MADE: 08-APR-09
ROSELLE, IL 60172-1684 510(k) STATEMENT
DEVICE: TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE C
ARK DIAGNOSTICS,INC 510(k) NO: K083799(TRADITIONAL)
ATTN: JOHNNY VALDEZ PHONE NO : 408-747-0706
1190 BORDEAUX DRIVE SE DECISION MADE: 16-APR-09
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROWICK
ARTHREX, INC. 510(k) NO: K083007(SPECIAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 08-APR-09
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ELECTROPHYSIOLOGY CATHETERS
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K090323(TRADITIONAL)
ATTN: KATIE BRAY PHONE NO : 480-763-5386
10232 SOUTH 51ST ST. SE DECISION MADE: 01-APR-09
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMAN
ASTRA TECH, INC. 510(k) NO: K083871(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERR. SE DECISION MADE: 15-APR-09
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATMOS S041 WOUND
ATMOS INC. 510(k) NO: K090130(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 02-APR-09
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRE-FILLED CATHETER INFLATION SYRINGE
AVAIL MEDICAL PRODUCTS, INC. 510(k) NO: K090121(SPECIAL)
ATTN: PATRICIA A GOEREE PHONE NO : 949-263-5060
1900 EAST CARNEGIE AVE. SE DECISION MADE: 15-APR-09
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
B. BRAUN MEDICAL, INC. 510(k) NO: K090905(SPECIAL)
ATTN: ANGELA J CARAVELLA PHONE NO : 610-596-2966
901 MARCON BLVD. SE DECISION MADE: 27-APR-09
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARCO 5MP MAMMO, MODEL MDMG-5221
BARCO NV 510(k) NO: K090603(TRADITIONAL)
ATTN: ALBERT XTHONA PHONE NO : 503-748-6060
15425 SW BEAVERTON CREEK COURT SE DECISION MADE: 22-APR-09
BEAVERTON, OR 97006-5168 510(k) STATEMENT
DEVICE: NIO COLOR 3MP AND MDNC-3121
BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K090732(SPECIAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 20-APR-09
KORTRIJK, BELGIUM B-8500 510(k) STATEMENT
DEVICE: SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100
BECKMAN COULTER, INC. 510(k) NO: K082251(TRADITIONAL)
ATTN: MARINE BOYAJIAN PHONE NO : 714-993-6536
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 08-APR-09
MS 110 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92821
DEVICE: MD2000A VITAL SIGN MONITOR, MODEL MD2000A
BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K083466(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 03-APR-09
NO19, LN999, ZHONG SHAN NAN ER 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: I OPEN 0.5T
BEIJING WANDONG MEDICAL EQUIPMENT 510(k) NO: K090873(TRADITIONAL)
ATTN: WANG WEIMIN PHONE NO :
NO. 7, SANJIANFANG NANLI SE DECISION MADE: 10-APR-09
CHAO YANG DISTRICT, BEIJING, CHINA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIOCARDIA MORPH SHEATH GUIDE
BIOCARDIA, INC. 510(k) NO: K090999(TRADITIONAL)
ATTN: DAVID SNOW PHONE NO : 650-226-0133
125 SHOREWAY ROAD, SUITE B SE DECISION MADE: 15-APR-09
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
BIODRAIN MEDICAL, INC. 510(k) NO: K090759(TRADITIONAL)
ATTN: CHAD RUWE PHONE NO : 651-389-4800
2060 CENTRE POINTE BLVD SE DECISION MADE: 01-APR-09
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
MENDOTA HEIGHTS, MN 55120-1269 THIRD PARTY REVIEW
DEVICE: ZETAJET
BIOJECT, INC. 510(k) NO: K090003(ABBREVIATED)
ATTN: KRIS RICHARD PHONE NO : 503-692-8001
20245 S.W. 95TH AVE. SE DECISION MADE: 02-APR-09
TUALATIN, OR 97062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZLASE
BIOLASE TECHNOLOGY, INC. 510(k) NO: K083595(TRADITIONAL)
ATTN: IOANA RIZOUI PHONE NO : 949-226-8144
4 CROMWELL SE DECISION MADE: 14-APR-09
IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS CA 125 II ASSAY
BIOMERIEUX, INC. 510(k) NO: K080561(TRADITIONAL)
ATTN: SANDRA L PERREAND PHONE NO : 314-731-8594
595 ANGLUM RD. SE DECISION MADE: 10-APR-09
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAK OSS KNEE FEMORAL COMPONENTS
BIOMET MANUFACTURING CORP. 510(k) NO: K083779(TRADITIONAL)
ATTN: PATRICIA S BERES PHONE NO : 574-267-6639
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 03-APR-09
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGENEREX PATELLA COMPONENTS
BIOMET MANUFACTURING CORP. 510(k) NO: K083782(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 03-APR-09
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERGRO DBM
BIOMET SPINE 510(k) NO: K082793(TRADITIONAL)
ATTN: KATHLEEN IDEO PHONE NO : 949-453-3200
181 TECHNOLOGY DR. SE DECISION MADE: 02-APR-09
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK-141 PATIENT CABLE
BIOTRONIK, INC. 510(k) NO: K083674(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN ROAD SE DECISION MADE: 01-APR-09
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE SKY BIO PLAN, VERSION .38
BLUE SKY BIO, LLC 510(k) NO: K090607(TRADITIONAL)
ATTN: ALBERT ZICKMANN PHONE NO : 847-548-8499
888 E BELVIDERE RD. SE DECISION MADE: 22-APR-09
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
GRAYSLAKE, IL 60030
DEVICE: BLUESHINE GOLD SERIES
BLUESHINE SRL 510(k) NO: K090297(TRADITIONAL)
ATTN: CHIARA RICCI PHONE NO : 390 041 5055847
VIA QUERINI, 27 SE DECISION MADE: 14-APR-09
MESTRE, VENICE, ITALY 30171 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K083374(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 508-683-4454
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 22-APR-09
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K083627(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 508-683-4454
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 07-APR-09
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINE & TRAUMA ICT
BRAINLAB AG 510(k) NO: K083310(SPECIAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680
KAPELLENSTRASSE 12 SE DECISION MADE: 01-APR-09
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
BRAINLAB AG 510(k) NO: K083483(TRADITIONAL)
ATTN: MICHAEL HOTTNER PHONE NO : 498 999 15680
KAPELLENSTRASSE 12 SE DECISION MADE: 08-APR-09
FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YIELD MINI DOPPLER SYSTEM
BRONCUS TECHNOLOGIES, INC. 510(k) NO: K090743(TRADITIONAL)
ATTN: NANCY ISAAC PHONE NO :
1400N SHORELINE BLVD. SE DECISION MADE: 03-APR-09
BLDG. A, SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94043 THIRD PARTY REVIEW
DEVICE: YIELD TISSUE SAMPLER
BRONCUS TECHNOLOGIES, INC. 510(k) NO: K090853(TRADITIONAL)
ATTN: NANCY ISAAC PHONE NO :
1400 N. SHORELINE BLVD. BLDG A SE DECISION MADE: 07-APR-09
SUITE 8 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VEIW, CA 94043 THIRD PARTY REVIEW
DEVICE: INTRAVENOUS POWER INJECTOR EXTENSION SET
C.R. BARD, INC. 510(k) NO: K090134(TRADITIONAL)
ATTN: SCOTT PEASE PHONE NO : 770-784-6774
8195 INDUSTRIAL BLVD. SE DECISION MADE: 21-APR-09
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM
CARDICA, INC. 510(k) NO: K090872(SPECIAL)
ATTN: KIMBERLEE LEON PHONE NO : 650-331-7119
900 SAGINAW DR. SE DECISION MADE: 21-APR-09
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
CARDICA, INC. 510(k) NO: K091017(SPECIAL)
ATTN: KIMBERLEE LEON PHONE NO : 650-331-7119
900 SAGINAW DR. SE DECISION MADE: 29-APR-09
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
CAREMATE MEDICAL DEVICE CO., LTD 510(k) NO: K090014(TRADITIONAL)
ATTN: XIAOMING HONG PHONE NO : 86 21 64264467
SUITE 8D, NO. 19, LANE 999 SE DECISION MADE: 09-APR-09
ZHONGSHAN NO.2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: CARESTREAM DRX-1 SYSTEM
CARESTREAM HEALTH, INC. 510(k) NO: K090318(TRADITIONAL)
ATTN: CHRISTINE EHMANN PHONE NO : 585-627-6473
1049 WEST RIDGE ROAD SE DECISION MADE: 06-APR-09
ROCHESTER, NY 14615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEMPAQ XBC ANALYZER
CHEMPAQ A/S 510(k) NO: K090013(SPECIAL)
ATTN: LONE HOFFENSETS PHONE NO : 44 443 90500
HIRSEMARKEN 1B SE DECISION MADE: 21-APR-09
FARUM, DENMARK DK-3520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
CIBA VISION CORPORATION 510(k) NO: K083216(SPECIAL)
ATTN: MARTINA HEIM PHONE NO : 678-415-3565
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 14-APR-09
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V
CLARUS MEDICAL, LLC. 510(k) NO: K082038(TRADITIONAL)
ATTN: THOMAS BARTHEL PHONE NO : 612-525-8401
1000 BOONE AVE. NORTH SE DECISION MADE: 28-APR-09
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55427
DEVICE: CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
CLINIQA CORPORATION 510(k) NO: K083554(TRADITIONAL)
ATTN: DAWN GAST PHONE NO : 760-744-1900
288 DISTRIBUTION STREET SE DECISION MADE: 21-APR-09
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
COLOPLAST A/S 510(k) NO: K090217(TRADITIONAL)
ATTN: SURESH GHAL PHONE NO : 612-287-4174
1601 WEST RIVER ROAD N SE DECISION MADE: 23-APR-09
MINNEAPOLIS, MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL
COMDEK INDUSTRIAL CORP. 510(k) NO: K083351(TRADITIONAL)
ATTN: Y.S. KUO PHONE NO : 886 2 26557810
9F-1, NO. 3 YUAN QU STREET SE DECISION MADE: 24-APR-09
NAN KANG 510(k) STATEMENT
TAIPEI, CHINA (TAIWAN) 11503
DEVICE: COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
COOK VASCULAR INC. 510(k) NO: K083482(TRADITIONAL)
ATTN: JIM FERGUSON, JR. PHONE NO : 724-845-8621
1186 MONTGOMERY LANE SE DECISION MADE: 02-APR-09
VANDERGRIFT, PA 15690 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK MREYE EMBOLIZATION COILS
COOK, INC. 510(k) NO: K090624(SPECIAL)
ATTN: SUSANNE GALIN PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 02-APR-09
BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER
COOK, INC. 510(k) NO: K090822(SPECIAL)
ATTN: NATHAN SIMON PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 27-APR-09
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004
CORESPINE TECHNOLOGIES, LLC 510(k) NO: K090303(TRADITIONAL)
ATTN: BRITT K NORTON PHONE NO : 612-940-7670
5909 BAKER ROAD SE DECISION MADE: 30-APR-09
SUITE 550 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55345
DEVICE: MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
COTTON HIGH TECH SL 510(k) NO: K091084(TRADITIONAL)
ATTN: ELENA GOMEZ PHONE NO : 349 383 91628
CTRA NAVAS A PRATS DE LLUCANES SE DECISION MADE: 29-APR-09
KM 1,5 GAIA 510(k) SUMMARY AVAILABLE FROM FDA
BARCELONA, SPAIN 08679 THIRD PARTY REVIEW
DEVICE: TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBE
COVIDIEN 510(k) NO: K090352(SPECIAL)
ATTN: TED KUHN PHONE NO : 303-305-2272
6135 GUNBARREL AVE. SE DECISION MADE: 03-APR-09
BOULDER, CO 80516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS/NMES/FES STIMULATING ELECTRODE
COVIDIEN LP 510(k) NO: K083350(TRADITIONAL)
ATTN: WEI ZHAO PHONE NO : 508-261-8404
15 HAMPSHIRE ST. SE DECISION MADE: 21-APR-09
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UN
COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K083519(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-492-6060
60 MIDDLETOWN AVENUE SE DECISION MADE: 10-APR-09
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 8
COVIDIEN, FORMERLY NELLCOR PURITAN510(k) NO: K083693(TRADITIONAL)
ATTN: KIM BLOOM PHONE NO : 760-603-5076
2101 FARADAY AVENUE SE DECISION MADE: 02-APR-09
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS IMPLANT SYSTEM- MINI PLUS
COWELLMEDI CO., LTD 510(k) NO: K090049(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 20-APR-09
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL
CYNOSURE, INC. 510(k) NO: K090618(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 14-APR-09
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-FIX SYSTEM
DENTIS CO. LTD. 510(k) NO: K083586(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562-404-8466
13340 E FIRESTONE BLVD SE DECISION MADE: 29-APR-09
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K083841(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-849-4229
221 WEST PHILADELPHIA ST. SE DECISION MADE: 14-APR-09
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: RIGIDFIX BIOCRYL CROSS PIN KITS
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K090669(SPECIAL)
ATTN: ZHENG LIU PHONE NO : 508-977-3966
325 PARAMOUNT DR. SE DECISION MADE: 03-APR-09
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K090799(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508-828-3288
325 PARAMOUNT DR. SE DECISION MADE: 22-APR-09
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DINKLER SURGICAL SKULL CLAMP, MODEL 0308
DINKLER SURGICAL DEVICES, INC. 510(k) NO: K090695(TRADITIONAL)
ATTN: CHARLES E DINKLER III PHONE NO : 513-310-0017
174 LOOKOUT DRIVE SE DECISION MADE: 23-APR-09
DAYTON, OH 45419 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
E-WOO TECHNOLOGY 510(k) NO: K090171(TRADITIONAL)
ATTN: VINCENT LEE PHONE NO : 281-598-8110
256 NORTH SAM HOUSTON PKWY E. SE DECISION MADE: 30-APR-09
SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77060
DEVICE: DETLOGIX ANNULOPLASTY RING, MODEL: 5100
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K083191(TRADITIONAL)
ATTN: MARTIN A KAUFMAN PHONE NO : 949-250-2708
ONE EDWARDS WAY SE DECISION MADE: 10-APR-09
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K083623(TRADITIONAL)
ATTN: ERICA WALTERS PHONE NO : 949-250-2438
ONE EDWARDS WAY SE DECISION MADE: 15-APR-09
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMINENT SPINE INTERBODY FUSION SYSTEM
EMINENT SPINE 510(k) NO: K090064(TRADITIONAL)
ATTN: DAVE FREEHILL PHONE NO : 512-484-6528
16001 RONALD REAGAN BLVD. SE DECISION MADE: 09-APR-09
LEANDER, TX 78641 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)
EUROIMMUN US INC 510(k) NO: K082130(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-270-0912
95 WASHINGTON ST SE DECISION MADE: 07-APR-09
MORRISTOWN, NJ 07960 510(k) STATEMENT
DEVICE: EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
EUROIMMUN US INC 510(k) NO: K083381(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-270-0912
95 WASHINGTON ST SE DECISION MADE: 15-APR-09
MORRISTOWN, NJ 07960 510(k) STATEMENT
DEVICE: HYPERGLIDE OCCLUSION BALLOON SYSTEM
EV3 INC. 510(k) NO: K090728(SPECIAL)
ATTN: JASON K LYON PHONE NO : 949-680-1293
9775 TOLEDO WAY SE DECISION MADE: 16-APR-09
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEERABLE GUIDE CATHETER
EVALVE INC 510(k) NO: K083793(TRADITIONAL)
ATTN: KARUNA VELUSAMY PHONE NO : 650-330-8100
4045 CAMPBELL AVENUE SE DECISION MADE: 27-APR-09
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATION CFS PRESS-FIT AND CEMENTED STEMS
EXACTECH, INC. 510(k) NO: K090764(SPECIAL)
ATTN: TARA R PATTERSON PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 21-APR-09
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWABCAP
EXCELSIOR MEDICAL CORP. 510(k) NO: K083508(TRADITIONAL)
ATTN: ROSHANA AHMED PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 28-APR-09
DUNDAS, ON, CANADA L2H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRONIC HOUSE CALL
EXPRESS MD SOLUTIONS, LLC 510(k) NO: K090801(TRADITIONAL)
ATTN: CHRIS DOHERTY PHONE NO : 617-595-2700
2001 BOMER DRIVE SE DECISION MADE: 08-APR-09
SUITE 3 510(k) SUMMARY AVAILABLE FROM FDA
PALM BEACH GARDENS, FL 33418 THIRD PARTY REVIEW
DEVICE: EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
EXTREMITY MEDICAL LLC 510(k) NO: K082934(TRADITIONAL)
ATTN: JAMY GANNOE PHONE NO : 973-588-8980
300 INTERPACE PARKWAY SE DECISION MADE: 23-APR-09
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
PARSIPPANY, NJ 07054
DEVICE: FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
FOTONA D.D. 510(k) NO: K083889(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 1 5009100
STEGNE 7, SE DECISION MADE: 23-APR-09
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL,
FUJINON, INC. 510(k) NO: K090116(TRADITIONAL)
ATTN: MASAYUKI OOYATSU PHONE NO : 814 866 82095
1-324 UETAKE-CHO SE DECISION MADE: 22-APR-09
KITA- KU SAITAMA, JAPAN 331-9624 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGATOR APPLICATIONS SUITE
GE HEALTHCARE FINLAND OY 510(k) NO: K083098(TRADITIONAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551
3030 OHMEDA DRIVE SE DECISION MADE: 01-APR-09
PO BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707-7550
DEVICE: GE DATEX-OHMEDA S/5 ADU CARESTATION
GE HEALTHCARE FINLAND OY 510(k) NO: K090892(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551
3030 OHMEDA DRIVE SE DECISION MADE: 30-APR-09
PO BOX 7550 510(k) SUMMARY AVAILABLE FROM FDA
MADISON, WI 53707-7550
DEVICE: MODIFICATION TO DASH 2500 PATIENT MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K090702(SPECIAL)
ATTN: DAVID WAHLIG PHONE NO : 414-362-3242
8200 WEST TOWER AVE. SE DECISION MADE: 15-APR-09
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
GENADYNE BIOTECHNOLOGIES, INC. 510(k) NO: K090638(SPECIAL)
ATTN: CHIEN-MING GOH PHONE NO : 516-487-8787
65 WATERMILL LANE SE DECISION MADE: 29-APR-09
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
GENX INTL., INC. 510(k) NO: K083509(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW RD. SE DECISION MADE: 24-APR-09
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: ONE STEP HCG URINE/SERUM TEST
GUANGZHOU WONDFO BIOTECH CO., LTD.510(k) NO: K072500(TRADITIONAL)
ATTN: HOWARD MANN PHONE NO : 215-369-3705
8903 SPRUCE MILL DRIVE SE DECISION MADE: 21-APR-09
YARDLEY, PA 19067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-
GYRUS ACMI, INC. 510(k) NO: K090814(SPECIAL)
ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508-804-2738
136 TURNPIKE RD. SE DECISION MADE: 20-APR-09
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
HARBINGER MEDICAL, INC. 510(k) NO: K090249(SPECIAL)
ATTN: HAROLD HOIUM PHONE NO : 952-943-1684
10125 CROSSTOWN CIRCLE SE DECISION MADE: 03-APR-09
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
EDEN PRAIRIE, MN 55344-3316
DEVICE: HG II FIXTURE SYSTEM
HIOSSEN INC. 510(k) NO: K090237(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 888-678-0001
85 BEN FAIRLESS DRIVE SE DECISION MADE: 17-APR-09
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
HOANA MEDICAL, INC. 510(k) NO: K083534(TRADITIONAL)
ATTN: NANCY GERTLAR PHONE NO : 808-523-1225
828 FORT STREET MALL SE DECISION MADE: 13-APR-09
SUITE 620 510(k) SUMMARY AVAILABLE FROM FDA
HONOLULU, HI 96825
DEVICE: HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUF
HYGIA HEALTH SERVICES, INC. 510(k) NO: K090074(TRADITIONAL)
ATTN: JEROME JAMES PHONE NO : 205-314-3920
434 INDUSTRIAL LN. SE DECISION MADE: 22-APR-09
BIRMINGHAM, AL 35211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINNING SPIROS, MODEL CH-2000
ICU MEDICAL, INC 510(k) NO: K082806(SPECIAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332
4455 ATHERTON DR. SE DECISION MADE: 06-APR-09
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
ICU MEDICAL, INC 510(k) NO: K090189(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332
4455 ATHERTON DR. SE DECISION MADE: 10-APR-09
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INCISIVE FAMILY OF INPULSE ND:YAG LASERS
INCISIVE, LLC. 510(k) NO: K083215(TRADITIONAL)
ATTN: ANN WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVENUE SE DECISION MADE: 08-APR-09
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K090506(TRADITIONAL)
ATTN: HELDER A SOUSA PHONE NO : 781-565-1235
4900 CHARLEMAR DR., SE DECISION MADE: 20-APR-09
BUILDING A 510(k) SUMMARY AVAILABLE FROM FDA
CINCINNATI, OH 45227
DEVICE: SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS T
INTER-MED, INC. 510(k) NO: K082470(TRADITIONAL)
ATTN: GEORGE HORVAT PHONE NO : 262-636-9755
2200 NORTHWESTERN AVE. SE DECISION MADE: 03-APR-09
RACINE, WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IM
INTERACOUSTICS AS 510(k) NO: K083861(TRADITIONAL)
ATTN: HANNE NIELSEN PHONE NO : 45 637 13555
DREJERVAENGET 8 SE DECISION MADE: 09-APR-09
ASSENS, DENMARK DK-5610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BILI BLUE F20T12/BBY AND F40T12/BBY
INTERLECTRIC CORP. 510(k) NO: K090192(TRADITIONAL)
ATTN: KEN C FRAZIER PHONE NO : 814-723-6061
1401 LEXINGTON AVE. SE DECISION MADE: 24-APR-09
WARREN, PA 16365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
INVUITY, INC. 510(k) NO: K090070(TRADITIONAL)
ATTN: KIT CARIQUITAN PHONE NO : 408-400-0856
155-A MOFFETT PARK DRIVE SE DECISION MADE: 22-APR-09
SUITE 210 510(k) SUMMARY AVAILABLE FROM FDA
SUNNYVALE, CA 94089
DEVICE: IBA PROTON THERAPY SYSTEM - PROTEUS 235
ION BEAM APPLICATIONS S.A. 510(k) NO: K083058(TRADITIONAL)
ATTN: JOHN B REISS PHONE NO : 215-972-7777
1500 MARKET STREET SE DECISION MADE: 15-APR-09
CENTRE SQUARE WEST, 38TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19102
DEVICE: MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
IRADIMED CORPORATION 510(k) NO: K090087(TRADITIONAL)
ATTN: FRANCIS X CASEY PHONE NO : 407-677-8022
7457 ALOMA AVE., SUITE 201 SE DECISION MADE: 07-APR-09
WINTER PARK, FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ISKRA MEDICAL GREEN IRF PRESTIGE
ISKRA MEDICAL, D.O.O. 510(k) NO: K083590(TRADITIONAL)
ATTN: MOJCA VALJAVEC PHONE NO : 386 41 641386
STEGNE 23 SE DECISION MADE: 17-APR-09
LJUBLJANA, SLOVENIA 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPRESS DIRECT
IVOCLAR VIVADENT, INC. 510(k) NO: K090701(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 29-APR-09
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: ALEUTIAN IBF SYSTEM
K2M, INC. 510(k) NO: K082698(TRADITIONAL)
ATTN: RICHARD WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 21-APR-09
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREMISE MODIFIED
KERR CORP. 510(k) NO: K090292(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602
1717 W. COLLINS AVENUE SE DECISION MADE: 03-APR-09
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K090963(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 30-APR-09
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, INC. 510(k) NO: K083581(SPECIAL)
ATTN: ANDREW LAMBORNE PHONE NO : 303-443-7500
390 INTERLOCKEN CRESCENT SE DECISION MADE: 07-APR-09
SUITE 890 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80021
DEVICE: LANX FUSION SYSTEM
LANX, INC. 510(k) NO: K083815(TRADITIONAL)
ATTN: ALAN BURKHOLDER PHONE NO : 303-443-7500
390 INTERLOCKEN CRESCENT SE DECISION MADE: 20-APR-09
SUITE 890 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80021
DEVICE: MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM
LANX, INC. 510(k) NO: K090316(SPECIAL)
ATTN: ANDREW LAMBORNE PHONE NO : 303-443-7500
390 INTERLOCKEN CRESCENT SE DECISION MADE: 07-APR-09
SUITE 890 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80021
DEVICE: HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
LASEROPTEK CO. LTD. 510(k) NO: K083203(TRADITIONAL)
ATTN: PHILLIP CHEON PHONE NO : 800-580-0789
22750 HAWTHORNE BLVD. SE DECISION MADE: 28-APR-09
SUITE 211 510(k) SUMMARY AVAILABLE FROM FDA
TORRANCE, CA 90505
DEVICE: CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES
LINVATEC CORP. 510(k) NO: K090186(SPECIAL)
ATTN: JOY LOVETT PHONE NO : 727-399-5137
11311 CONCEPT BLVD. SE DECISION MADE: 10-APR-09
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODE
MAINE STANDARDS CO. 510(k) NO: K090475(TRADITIONAL)
ATTN: HOLLY CRESSMAN PHONE NO : 207-892-1300
765 ROOSEVELT TRAIL SE DECISION MADE: 16-APR-09
WINDHAM, ME 04062-5365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECC SET WITH BIOLINE COATING
MAQUET CARDIOPULMONARY AG 510(k) NO: K083794(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 478921151
HECHINGER STRASSE 38 SE DECISION MADE: 21-APR-09
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD MONITORING UNIT, MODEL BMU 40
MAQUET CARDIOPULMONARY AG 510(k) NO: K090147(TRADITIONAL)
ATTN: ANASTASIA MUELLER PHONE NO : 49 747 89210
HECHINGER STRASSE 38 SE DECISION MADE: 22-APR-09
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LNCS OXIMETRY SENSORS
MASIMO CORPORATION 510(k) NO: K083622(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 02-APR-09
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREEDOM METAL BACKED TIBIAL COMPONENT
MAXX ORTHOPEDICS, INC. 510(k) NO: K090411(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 07-APR-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSAFIT CUP DOUBLE MOBILITY SYSTEM
MEDACTA INTERNATIONAL, SA 510(k) NO: K083116(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 07-APR-09
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS 2.0 RADIAL HEAD SYSTEM
MEDARTIS AG 510(k) NO: K090053(TRADITIONAL)
ATTN: KEVIN THOMAS PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE 200 SE DECISION MADE: 23-APR-09
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTE
MEDTRONIC SOFAMOR DANEK 510(k) NO: K090714(SPECIAL)
ATTN: MELISA LANSKY PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 17-APR-09
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERETE LOCKING BONE PLATE SYSTEM
MERETE MEDICAL, INC. 510(k) NO: K090063(TRADITIONAL)
ATTN: JORG MIETZNER PHONE NO : 914-967-1532
49 PURCHASE ST. SE DECISION MADE: 22-APR-09
RYE, NY 10580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGUIDE CHRONIC DIALYSIS CATHETER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K090148(TRADITIONAL)
ATTN: SUSAN CHRISTENSEN PHONE NO : 801-208-4789
1600 WEST MERIT PKWY. SE DECISION MADE: 13-APR-09
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROFRAME (HES)
MICROVENTION, INC. 510(k) NO: K090357(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-951-0516
75 COLUMBIA SE DECISION MADE: 10-APR-09
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVER WOUND PAD
MILLIKEN & CO. 510(k) NO: K083659(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 16-APR-09
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
MILLIPORE CORPORATION 510(k) NO: K081527(TRADITIONAL)
ATTN: ALISHA VU PHONE NO : 951-676-8080
28820 SINGLE OAK DR. SE DECISION MADE: 01-APR-09
TEMECULA, CA 92590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REBOUND HRDV
MINNESOTA MEDICAL DEVELOPMENT, INC510(k) NO: K083467(SPECIAL)
ATTN: STEVE NUSS PHONE NO : 763-354-7100
14305 21ST AVE. NORTH SE DECISION MADE: 23-APR-09
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: MPS ACACIA POWER INJECTABLE INFUSION SET
MPS ACACIA 510(k) NO: K090809(TRADITIONAL)
ATTN: FERGIE FERGUSON PHONE NO : 714-257-0470
785 CHALLENGER ST. SE DECISION MADE: 28-APR-09
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRIMADO
NAKANISHI, INC. 510(k) NO: K083112(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K STREET, N.W. SE DECISION MADE: 29-APR-09
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K090215(TRADITIONAL)
ATTN: ANGUS HSU PHONE NO : 886 226 037288
1F, NO. 181, SEC. 2 WUNHUA SE DECISION MADE: 15-APR-09
1ST ROAD, LINKOU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPE, CHINA (TAIWAN) 244 THIRD PARTY REVIEW
DEVICE: MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K090218(TRADITIONAL)
ATTN: ANGUS HSU PHONE NO : 886 226 037288
1F, NO. 181, SEC. 2 WUNHUA SE DECISION MADE: 15-APR-09
1ST ROAD, LINKOU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPE, CHINA (TAIWAN) 244 THIRD PARTY REVIEW
DEVICE: NEUTROLUMENPN SYSTEM, MODEL 1000
NEUROLUMEN, LLC 510(k) NO: K082223(TRADITIONAL)
ATTN: SHELLY HENRY PHONE NO : 405-210-8281
11108 ASHFORD DRIVE SE DECISION MADE: 21-APR-09
YUKON, OK 73099 510(k) STATEMENT
DEVICE: ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESI
NEUSOFT POSITRON MEDICAL SYSTEMS C510(k) NO: K090178(TRADITIONAL)
ATTN: SUN YAN PHONE NO : 860 248 3662197
NO. 16M SHIJI ROAD SE DECISION MADE: 24-APR-09
HUNNAN NEW DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110179
DEVICE: NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
NOVABONE PRODUCTS, LLC 510(k) NO: K090731(SPECIAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 15-APR-09
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
NUVASIVE, INC. 510(k) NO: K090176(SPECIAL)
ATTN: HAN FAN PHONE NO : 858-909-3358
7475 LUSK BLVD SE DECISION MADE: 27-APR-09
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: GIRAFFE AND PANDA WARMER
OHMEDA MEDICAL 510(k) NO: K090697(SPECIAL)
ATTN: AGATA SMIEJA PHONE NO : 410-456-0329
8880 GORMAN RD. SE DECISION MADE: 16-APR-09
LAUREL, MD 20723 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACK WIDOW ANTERIOR BUTTRESS PLATE
OMNI SURGICAL, L.P. 510(k) NO: K081770(TRADITIONAL)
ATTN: JOSHUA KAUFMAN PHONE NO : 512-772-3774
5000 PLAZA ON THE LAKE SE DECISION MADE: 02-APR-09
SUITE 305 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: ORTHO T. CRUZI ELISA TEST SYSTEM
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K072732(TRADITIONAL)
ATTN: ANDREA J CASPER PHONE NO : 908-218-8532
1001 U.S. HWY. 202 SE DECISION MADE: 15-APR-09
RARITAN, NJ 08869-0606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOSTAT
ORTHOCON, INC. 510(k) NO: K091121(SPECIAL)
ATTN: KENNETH A COLLINS PHONE NO : 732-418-0025
675 US HIGHWAY ONE SE DECISION MADE: 28-APR-09
NORTH BRUNSWICK, NJ 08902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIPLATES
ORTHOPEDIATRICS, CORP. 510(k) NO: K090666(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379
210 N. BUFFALO ST. SE DECISION MADE: 24-APR-09
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAPCONE
OTTO BOCK PUR LIFE SCIENCE GMBH 510(k) NO: K083012(TRADITIONAL)
ATTN: CHRISTIAN SCHULTE PHONE NO : 495 527 8481729
MAX-NAEDER-STR 15 SE DECISION MADE: 09-APR-09
DUDERSTADT, LOWER SAXONY, GERMANY 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: STIWELL MED4
OTTO BOCK, AUSTRIA GMBH 510(k) NO: K080950(TRADITIONAL)
ATTN: WILLIAM F JACKSON PHONE NO : 651-773-0002
2247 JENNIFER LANE SE DECISION MADE: 02-APR-09
NORTH ST. PAUL, MN 55109-2851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K090631(TRADITIONAL)
ATTN: CHRISTIAN G QUASS PHONE NO : 49 770 49192586
KARL-HALL-STRASSE 01 SE DECISION MADE: 16-APR-09
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASS
PHADIA US INC. 510(k) NO: K082759(TRADITIONAL)
ATTN: MARTIN R MANN PHONE NO : 269-492-1957
4169 COMMERCIAL AVE. SE DECISION MADE: 10-APR-09
PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PINNACLE3 SMARTARC
PHILIPS MEDICAL SYSTEMS, INC. 510(k) NO: K090808(TRADITIONAL)
ATTN: JILL KAEDER PHONE NO : 608-288-6941
5520 NOBEL DR. SE DECISION MADE: 03-APR-09
SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA
FITCHBURG, WI 53711 THIRD PARTY REVIEW
DEVICE: PIEZOSURGERY MEDICAL
PIEZOSURGERY SRL 510(k) NO: K083284(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 39 06 5782665
PIAZZA ALBANIA 10 SE DECISION MADE: 08-APR-09
ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER LUMBAR PLATE SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K090222(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 28-APR-09
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET
POSSIS MEDICAL, INC. 510(k) NO: K090253(TRADITIONAL)
ATTN: DOUG ATKINS PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 08-APR-09
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAXODENT
PREMIER DENTAL PRODUCTS CO. 510(k) NO: K083695(TRADITIONAL)
ATTN: VINCENT D'ALESSANDRO PHONE NO : 610-239-6000
1710 ROMANO DR. SE DECISION MADE: 28-APR-09
PLYMOUTH MEETING, PA 19462 510(k) STATEMENT
DEVICE: V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER
PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K090805(SPECIAL)
ATTN: THOMAS J SCHAPPERT PHONE NO : 570-655-5574
182 SUSQUEHANNA AVE. SE DECISION MADE: 03-APR-09
EXETER, PA 18643 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGASTRO CD ASSAY
PRODESSE, INC. 510(k) NO: K090239(TRADITIONAL)
ATTN: KRISTINE SCHRAUFNAGEL PHONE NO : 262-446-0700
W229 N 1870 WESTWOOD DR. SE DECISION MADE: 16-APR-09
WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
PT MAHAKARYA INTI BUANA 510(k) NO: K090464(TRADITIONAL)
ATTN: AZMAN ISMAIL PHONE NO : 626 130 007150
JL.SEI BELUMAI DESA DALU 10A SE DECISION MADE: 23-APR-09
DUSUN I 510(k) SUMMARY AVAILABLE FROM FDA
TANJUNG MORAWA, SUMUT, INDONESIA 20362
DEVICE: SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
QUANTUM CO., LTD. 510(k) NO: K083931(TRADITIONAL)
ATTN: LIJUAN WANG PHONE NO : 86 533 7480087
NO.2-3-18 HUA SHENG YUAN PARK SE DECISION MADE: 27-APR-09
LINZI 510(k) SUMMARY AVAILABLE FROM FDA
SHANDONG, CHINA 255410
DEVICE: NEOSALUS CREAM
QUINNOVA PHARMACEUTICALS 510(k) NO: K090585(TRADITIONAL)
ATTN: SHAHBAZ KHAN PHONE NO : 215-550-2005
411 S. STATE ST. 3RD. FLOOR SE DECISION MADE: 02-APR-09
NEWTOWN, PA 18940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
REAMETRIX INC. 510(k) NO: K082091(TRADITIONAL)
ATTN: STEVE KUNITAKE PHONE NO : 650-620-9253
1585 INDUSTRIAL RD. SE DECISION MADE: 15-APR-09
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLICATION MEDICAL VESSEL GUARD
REPLICATION MEDICAL INC 510(k) NO: K082782(TRADITIONAL)
ATTN: MARCOS VELEZ-DURAN PHONE NO : 703-562-9800
901 KING STREET SE DECISION MADE: 02-APR-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ALEXANDRIA, VA 22314
DEVICE: SWIFT FX
RESMED LTD. 510(k) NO: K090244(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 13-APR-09
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVI ROOT
S-DENTI CO., LTD. 510(k) NO: K083901(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
5401 S COTTONWOOD CT SE DECISION MADE: 15-APR-09
GREENWOOD VILLAGE, CO 80121 510(k) STATEMENT
DEVICE: PORTABLE OXYGEN UNIT SCA900
SAN CHEONG CO. LTD. 510(k) NO: K080243(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562-404-8466
13340 E FIRESTONE BLVD SE DECISION MADE: 07-APR-09
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
SASET (CHENGDU) INC. 510(k) NO: K090059(TRADITIONAL)
ATTN: DONG CHYUAN LIN PHONE NO : 862 885 352318
KEHUA NORTH ROAD #58 SE DECISION MADE: 30-APR-09
CHENGDU, SICHUAN, CHINA 610041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAMBRIA
SEASPINE, INC. 510(k) NO: K082309(TRADITIONAL)
ATTN: JEFF BRITTAN PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 09-APR-09
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPILLARYS IMMUNOTYPING, MODEL 2100
SEBIA 510(k) NO: K082085(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 770-446-3704
400-1705 CORPORATE DRIVE SE DECISION MADE: 17-APR-09
SUITE 400 510(k) STATEMENT
NORCROSS, GA 30093
DEVICE: MINICAP IMMUNOTYPING, MODEL: 2300
SEBIA 510(k) NO: K082388(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 770-446-3707
400-1705 CORPORATE DRIVE SE DECISION MADE: 14-APR-09
NORCROSS, GA 30093 510(k) STATEMENT
DEVICE: BLOOD TRANSFUSION SET
SHAN DONG WEI GAO GROUP MEDICAL PO510(k) NO: K083349(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467
STE.8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 10-APR-09
MANSION,NO.19, LANE 999, ZHONG 510(k) SUMMARY AVAILABLE FROM FDA
SHAN NAN ER RD., SHANGHAI, CHINA 200030
DEVICE: DS N95 SURGICAL MASKS AND FLAT SURGICAL
SHANGHAI DASHENG HEALTH PRODUCTS 510(k) NO: K090131(ABBREVIATED)
ATTN: MAGGIE ZHONG PHONE NO : 862 133 907930
SONGJIANG DISTRICT SE DECISION MADE: 27-APR-09
SHANGHAI, CHINA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K090912(TRADITIONAL)
ATTN: TAN CHUANBIN PHONE NO : 86 755 26582888
MINDRAY BLDG,KEJI 12TH RD. S. SE DECISION MADE: 15-APR-09
HI-TECH INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NANSHAN, SHENZHEN, GUANGDONG, CHINTHIRD PARTY REVIEW
DEVICE: ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K083386(TRADITIONAL)
ATTN: CAROL BIANCA PHONE NO : 914-524-2531
511 BENEDICT AVENUE SE DECISION MADE: 02-APR-09
TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K090236(TRADITIONAL)
ATTN: JANET M FOSE PHONE NO : 302-631-8826
500 GBC DRIVE M/S 514 SE DECISION MADE: 27-APR-09
PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714
DEVICE: DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), A
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K090594(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
500 GBC DRIVE SE DECISION MADE: 29-APR-09
PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: SYNGO BREVIS
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K090038(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-761-1860
51 VALLEY STREAM PARKWAY SE DECISION MADE: 28-APR-09
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K083524(SPECIAL)
ATTN: CORRINE MCLEOD PHONE NO : 610-448-1772
51 VALLEY STREAM PKWY. SE DECISION MADE: 01-APR-09
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGYBONE
SILFRADENT S.R.L. 510(k) NO: K083569(ABBREVIATED)
ATTN: CLAUDE D BERTHOIN PHONE NO : 800-323-2690
110 E. GRANADA BLVD., STE. 207 SE DECISION MADE: 01-APR-09
ORMOND BEACH, FL 32176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
SINTEA BIOTECH, INC. 510(k) NO: K082679(SPECIAL)
ATTN: DANIELLE WERNIKOWSKI PHONE NO : 305-673-6226
407 LINCOLN RD. SUITE 10L SE DECISION MADE: 07-APR-09
MIAMI BEACH, FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKLAR SURGICAL GOWN
SKLAR CORP. 510(k) NO: K082479(TRADITIONAL)
ATTN: NATALYA VALERIO PHONE NO : 516-482-9001
55 NORTHERN BLVD SE DECISION MADE: 24-APR-09
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: BCI WW1020 PULSE OXIMETER, MODEL WW1020
SMITHS MEDICAL PM, INC. 510(k) NO: K083705(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-650-2984
N7 W22025 JOHNSON DR. SE DECISION MADE: 09-APR-09
WAUKESHA, WI 53186-1856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI WW1000 PULSE OXIMETER, MODEL WW1000
SMITHS MEDICAL PM, INC. 510(k) NO: K083787(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-650-2984
N7 W22025 JOHNSON DR. SE DECISION MADE: 15-APR-09
WAUKESHA, WI 53186-1856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCI WW1021 PC APPLICATION
SMITHS MEDICAL PM, INC. 510(k) NO: K090205(TRADITIONAL)
ATTN: DONALD ALEXANDER PHONE NO : 262-542-3100
N7 W22025 JOHNSON DR. SE DECISION MADE: 28-APR-09
WAUKESHA, WI 53186-1856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSTREAM LOW LEVEL LASER
SOLICA CORPORATION 510(k) NO: K081166(TRADITIONAL)
ATTN: CARLA WINSLOW PHONE NO : 416 868 1717 226
129 YORKVILLE AVENUE SE DECISION MADE: 03-APR-09
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
TORONTO, ONTARIO, CANADA M5R 1C4
DEVICE: INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
SOMANETICS CORP. 510(k) NO: K082327(TRADITIONAL)
ATTN: RONALD A WIDMAN PHONE NO : 248-689-3050
1653 EAST MAPLE RD. SE DECISION MADE: 03-APR-09
TROY, MI 48083-4208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPRO 184 CAMERA
SOPRO 510(k) NO: K082796(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 01-APR-09
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: SPEC MODEL M-31
SOURCE PRODUCTION & EQUIPMENT CO.,510(k) NO: K090366(TRADITIONAL)
ATTN: JOHN J MUNRO PHONE NO : 504-464-9471
113 TEAL STREET SE DECISION MADE: 22-APR-09
ST. ROSE, LA 70087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONIT
SPACELABS HEALTHCARE MEDICAL EQUIP510(k) NO: K090556(TRADITIONAL)
ATTN: THOMAS KROENKE PHONE NO : 303-956-4232
P.O. BOX 3018 SE DECISION MADE: 30-APR-09
NEDERLAND, CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINESMITH CYNCH SPINAL SYSTEM
SPINE SMITH PARTNERS L.P. 510(k) NO: K090376(TRADITIONAL)
ATTN: ROBERT JONES PHONE NO : 512-206-0770
8140 N. MOPAC SE DECISION MADE: 01-APR-09
BLDG II, SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: ENSPIRE DEBRIDER SYSTEM
SPINE VIEW, INC. 510(k) NO: K090278(TRADITIONAL)
ATTN: SANDRA SUNDELL PHONE NO : 510-585-5345
48541 WARM SPRINGS BLVD. SE DECISION MADE: 15-APR-09
SUITE 507 510(k) SUMMARY AVAILABLE FROM FDA
FREMONT, CA 94539
DEVICE: PARADIS VASO SHIELD
SPINEMEDICA, LLC 510(k) NO: K090022(TRADITIONAL)
ATTN: SALLY THORSEN PHONE NO : 678-384-6720
811 LIVINGSTON COURT SE DECISION MADE: 20-APR-09
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
MARIETTA, GA 30067
DEVICE: STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
ST. JUDE MEDICAL 510(k) NO: K090163(TRADITIONAL)
ATTN: GEENA GEORGE PHONE NO : 818-493-2629
15900 VALLEY VIEW COURT SE DECISION MADE: 01-APR-09
SYLMAR,, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMUM/ENGAGE/ENGAGE TR
ST. JUDE MEDICAL 510(k) NO: K091137(TRADITIONAL)
ATTN: LINH PHAM PHONE NO : 763-383-0900
14901 DEVEAU PL. SE DECISION MADE: 22-APR-09
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AVS ANTERIOR LARGE PEEK SPACERS
STRYKER CORP. 510(k) NO: K090166(TRADITIONAL)
ATTN: VIKKI M O'CONNOR PHONE NO : 201-760-8215
2 PEARL COURT SE DECISION MADE: 22-APR-09
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE AVS PL PEEK SPACERS
STRYKER CORP. 510(k) NO: K090816(SPECIAL)
ATTN: VIKKI M O'CONNOR PHONE NO : 201-760-8215
2 PEARL COURT SE DECISION MADE: 24-APR-09
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA 3 SPINAL SYSTEM
STRYKER SPINE 510(k) NO: K083393(TRADITIONAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296
2 PEARL COURT SE DECISION MADE: 01-APR-09
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
SURGICAL DEVICES, TYCO HEALTHCARE 510(k) NO: K091087(SPECIAL)
ATTN: JENNIFER BRENNAN PHONE NO : 203-492-5346
60 MIDDLETOWN AVE. SE DECISION MADE: 22-APR-09
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
SURGICAL TECHNOLOGY LABORATORIES, 510(k) NO: K091011(TRADITIONAL)
ATTN: MATHEW FAIRFAX PHONE NO : 803-462-1714
610 CLEMSON ROAD SE DECISION MADE: 22-APR-09
COLUMBIA, SC 29229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW
SYNTEC SCIENTIFIC CORP. 510(k) NO: K090839(SPECIAL)
ATTN: CAROL CHANG PHONE NO : 886 2 27787396
3F1. 96 CHUNG HSIAO E. RD. SE DECISION MADE: 24-APR-09
SEC. 3 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 106
DEVICE: SYNTHES 90 DEGREE SCREWDRIVER
SYNTHES (USA) 510(k) NO: K082649(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 610-719-6920
1301 GOSHEN PKWY. SE DECISION MADE: 30-APR-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
SYNTHES (USA) 510(k) NO: K090047(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941
1301 GOSHEN PKWY. SE DECISION MADE: 01-APR-09
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATARJET CORTICAL SCREW SET
T.A.G. MEDICAL PRODUCTS 510(k) NO: K083096(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 17-APR-09
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM; ACHTUNG BLOOD GLUCO
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K090185(SPECIAL)
ATTN: SOPHIE LIN PHONE NO : 886 2 66258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 24-APR-09
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: CLUE MEDICAL AND CLUE MEDICAL BASIC
TELOVITAL GMBH TELEMEDIZIN 510(k) NO: K083630(SPECIAL)
ATTN: CHERITA JAMES PHONE NO : 703-562-9800
901 KING ST., SUITE 200 SE DECISION MADE: 23-APR-09
ALEXANDRIA, VA 22314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO PALL AL6X ARTERIAL FILTER
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K083834(TRADITIONAL)
ATTN: EILEEN DORSEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 17-APR-09
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANN
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K090878(SPECIAL)
ATTN: CHRISTINA THOMAS PHONE NO : 734-663-4145
6200 JACKSON RD. SE DECISION MADE: 03-APR-09
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
TERUMO MEDICAL CORP. 510(k) NO: K082997(TRADITIONAL)
ATTN: EILEEN DORSEY PHONE NO : 410-392-7241
950 ELKTON BLVD. SE DECISION MADE: 15-APR-09
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIGDOP ULTRASOUND SYSTEM
THE NEWMAN GROUP, LLC 510(k) NO: K090465(TRADITIONAL)
ATTN: SPENCER NEWMAN PHONE NO : 847-283-9177
42 SHERWOOD TERRACE SE DECISION MADE: 08-APR-09
SUITE 2 510(k) STATEMENT
LAKE BLUFF, IL 60044 THIRD PARTY REVIEW
DEVICE: ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
TITAN SPINE, LLC 510(k) NO: K083714(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999
13540 GUILD AVE SE DECISION MADE: 15-APR-09
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALGREEN'S PERSONAL LUBRICATING JELLY
TOPCO SALES 510(k) NO: K080978(TRADITIONAL)
ATTN: LORELEI CHAVEZ PHONE NO : 818-332-4790
9401 DE SOTO AVE. SE DECISION MADE: 23-APR-09
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEROCHAMBER MINI VENTILATION CHAMBER
TRUDELL MEDICAL INTL. 510(k) NO: K090065(TRADITIONAL)
ATTN: DARRYL FISCHER PHONE NO : 519 455 7060 X2140
725 THIRD ST. SE DECISION MADE: 09-APR-09
LONDON, ONTARIO, CANADA N5V 5G4 510(k) STATEMENT
DEVICE: RTX 3371
TUNSTALL HEALTHCARE 510(k) NO: K090886(TRADITIONAL)
ATTN: NIELS OLE ANDERSON PHONE NO : 45 72 100163
STROEMMEN 6 SE DECISION MADE: 15-APR-09
NOERRESUNDBY, NORWAY DK-9400 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OPAL SEAL
ULTRADENT PRODUCTS, INC. 510(k) NO: K090355(TRADITIONAL)
ATTN: DIANE ROGERS PHONE NO : 801-553-4491
505 WEST 10200 SOUTH SE DECISION MADE: 29-APR-09
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL
VASOMEDICAL, INC. 510(k) NO: K083820(TRADITIONAL)
ATTN: MELISSA PURPURA PHONE NO : 516-997-4600
180 LINDEN AVE. SE DECISION MADE: 01-APR-09
WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVENT PROFESSIONAL SLEEP APNEA THERAPY
VENTUS MEDICAL, INC. 510(k) NO: K090398(TRADITIONAL)
ATTN: MARY ROSE PHONE NO : 650-832-6118
1301 SHOREWAY ROAD SE DECISION MADE: 03-APR-09
SUITE 425 510(k) SUMMARY AVAILABLE FROM FDA
BELMONT, CA 94002
DEVICE: WELL-PASTE
VERICOM CO., LTD. 510(k) NO: K090992(TRADITIONAL)
ATTN: JAY HWANG PHONE NO : 714-508-9462
2670 WALNUT AVE. SE DECISION MADE: 21-APR-09
SUITE N 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92780 THIRD PARTY REVIEW
DEVICE: VERTIGONE BPPV GOGGLE
VERTIGONE, INC. 510(k) NO: K082634(TRADITIONAL)
ATTN: JAYE THOMPSON PHONE NO : 281-367-6655
2202 TIMBERLOCH PLACE SE DECISION MADE: 07-APR-09
SUITE 230 510(k) SUMMARY AVAILABLE FROM FDA
WOODLANDS, TX 77380
DEVICE: EXTREME 4X4-X8 POWER WHEELCHAIR
VESTIL MANUFACTURING CORP. 510(k) NO: K090350(TRADITIONAL)
ATTN: RICK MICHAEL PHONE NO : 260-665-2769
201 GROWTH PKWY. SE DECISION MADE: 10-APR-09
ANGOLA, IN 46703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HE
VIDISTAR, LLC 510(k) NO: K083910(TRADITIONAL)
ATTN: CRAIG WALKER PHONE NO : 864-979-1767
PO BOX 8539 SE DECISION MADE: 15-APR-09
GREENVILLE, SC 29604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
VIOPTIX, INC. 510(k) NO: K090679(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 17-APR-09
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
WALLAC OY 510(k) NO: K081922(TRADITIONAL)
ATTN: KATRIINA SUONPAA PHONE NO : 358 2 2678111
MUSTIONKATU 6 SE DECISION MADE: 16-APR-09
TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WI
WEAR SAFE (MALAYSIA) SDN. BHD. 510(k) NO: K090327(TRADITIONAL)
ATTN: S.H. TAN PHONE NO : 603 329 12657
LOT PT 13726,JALAN HAJI SALLEH SE DECISION MADE: 03-APR-09
BATU 5 1/4 OFF JALAN MERU 510(k) SUMMARY AVAILABLE FROM FDA
KLANG, SELANGOR, MALAYSIA 41050
DEVICE: WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K082065(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DR SE DECISION MADE: 10-APR-09
BONTIA SPRING, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAGUARD, MODEL 3611001
WEST PHARMACEUTICAL SERVICES, INC.510(k) NO: K082908(ABBREVIATED)
ATTN: ARI Y SOBEL PHONE NO : 610-589-2900
101 GORDON DR. SE DECISION MADE: 24-APR-09
LIONVILLE, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING
WILLIAM A. COOK AUSTRALIA PTY, LTD510(k) NO: K082363(TRADITIONAL)
ATTN: GUS TADDEO PHONE NO : 617 384 11188
12 ELECTRONICS ST. SE DECISION MADE: 29-APR-09
EIGHT MILE PLAINS, QLD, AUSTRALIA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
WILLIAM COOK EUROPE APS 510(k) NO: K090140(SPECIAL)
ATTN: MOLLY BUSENBARK PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 03-APR-09
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: FLUID-FILLED TEETHER
WILTEC INDUSTRIES LTD. 510(k) NO: K083512(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
5401 S. COTTONWOOD CT SE DECISION MADE: 22-APR-09
GREENWOOD VILLAGE, CO 80121 510(k) STATEMENT
DEVICE: CALIX SPINAL IMPLANT SYSTEM
X-SPINE SYSTEMS, INC. 510(k) NO: K083637(TRADITIONAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937-847-8400
452 ALEXANDERSVILLE RD. SE DECISION MADE: 20-APR-09
MIAMISBURG, OH 45342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTA PROTECTIVE SHEET
XYLOS CORPORATION 510(k) NO: K090778(TRADITIONAL)
ATTN: JOYCE ELKINS PHONE NO : 215-867-0220
838 TOWN CENTER DR. SE DECISION MADE: 28-APR-09
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-70
YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K090058(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 22-APR-09
HSIN-CHU CITY, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIKCLOT INTEVENTIONAL, MODEL P/N 182
Z-MEDICA CORPORATION 510(k) NO: K090620(TRADITIONAL)
ATTN: RONALD E PETERSON PHONE NO : 203-294-0000
4 FAIRFIELD BLVD. SE DECISION MADE: 08-APR-09
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561
ZIMMER DENTAL INC. 510(k) NO: K090723(SPECIAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 07-APR-09
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 242
TOTAL WITH SUMMARIES 223
TOTAL WITH STATEMENTS 19
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