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Medical Devices
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May 2007 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-MAY-2007 THROUGH 31-MAY-2007
DEVICE: .DECIMAL APERTURE
.DECIMAL, INC. 510(k) NO: K071077(TRADITIONAL)
ATTN: DANIEL BENNETT PHONE NO : 407-330-3300
121 CENTRAL PARK PLACE SE DECISION MADE: 18-MAY-07
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: .DECIMAL RANGE COMPENSATOR
.DECIMAL, INC. 510(k) NO: K071078(TRADITIONAL)
ATTN: DANIEL BENNETT PHONE NO : 407-330-3300
121 CENTRAL PARK PLACE SE DECISION MADE: 22-MAY-07
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEA2 SELF ETCH ADHESIVE
3M ESPE DENTAL PRODUCTS 510(k) NO: K070956(TRADITIONAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326
3M CENTER; BLDG 260-2A-17 SE DECISION MADE: 22-MAY-07
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THYROSAMPLER
ACD MEDICAL INNOVATION CORP. 510(k) NO: K062979(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 30-MAY-07
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: ACQUASEAL BENZ
ACQUAMED TECHNOLOGIES, INC. 510(k) NO: K070289(TRADITIONAL)
ATTN: HUGH PALMER PHONE NO : 630-232-8704
33 WEST 480 FABYAN PARKWAY, SE DECISION MADE: 04-MAY-07
UNIT 105 510(k) SUMMARY AVAILABLE FROM FDA
WEST CHICAGO,, IL 60185
DEVICE: MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS
ACUMEN MEDICAL, INC. 510(k) NO: K070396(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 22-MAY-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K071014(SPECIAL)
ATTN: YOGI SHAH PHONE NO : 949-789-8548
33 TECHNOLOGY DR. SE DECISION MADE: 24-MAY-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERONEB PROFESSIONAL NEBULIZER SYSTEM
AEROGEN (IRELAND) LTD 510(k) NO: K070642(SPECIAL)
ATTN: FRANK ENRIGHT PHONE NO : 003 539 1502550
GALWAY BUSINESS PARK SE DECISION MADE: 07-MAY-07
DANGAN, GALWAY, IRELAND 510(k) STATEMENT
DEVICE: AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
AGFA HEALTHCARE CORP. 510(k) NO: K071162(TRADITIONAL)
ATTN: JEFFERY A JEDLICKA PHONE NO : 864-421-1815
10 SOUTH ACADEMY ST. SE DECISION MADE: 08-MAY-07
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K063545(ABBREVIATED)
ATTN: DAITING RONG PHONE NO : 858-513-3888
13200 GREGG ST. SE DECISION MADE: 07-MAY-07
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOVENT MODEL 4000
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K070120(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400
1720 SUBLETTE AVE. SE DECISION MADE: 03-MAY-07
ST.LOUIS, MO 63110 510(k) STATEMENT
DEVICE: AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES
ALPHA-OMEGA SERVICES, INC. 510(k) NO: K062823(TRADITIONAL)
ATTN: BOB A ROBNETT PHONE NO : 562-804-0604
9156 ROSE ST SE DECISION MADE: 29-MAY-07
BELLFLOWER, CA 90706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS MARKER SEEDS
ALPHA-OMEGA SERVICES, INC. 510(k) NO: K062825(TRADITIONAL)
ATTN: BOB A ROBNETT PHONE NO : 562-804-0604
9156 ROSE ST SE DECISION MADE: 22-MAY-07
BELLFLOWER, CA 90706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
ALPHA-OMEGA SERVICES, INC. 510(k) NO: K062826(TRADITIONAL)
ATTN: BOB A BOBNETT PHONE NO : 562-804-0604
9156 ROSE ST SE DECISION MADE: 22-MAY-07
BELLFLOWER, CA 90706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROC LUMBAR SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K063668(TRADITIONAL)
ATTN: PAULA MORGAN PHONE NO : 760-431-9286
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 18-MAY-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
ALPHATEC SPINE, INC. 510(k) NO: K070681(TRADITIONAL)
ATTN: PAULA MORGAN PHONE NO : 760-431-9286
2051 PALOMAR AIRPORT ROAD SE DECISION MADE: 04-MAY-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELE
AMBU A/S 510(k) NO: K071185(SPECIAL)
ATTN: SANJAY PARIKH PHONE NO : 410-768-6464
6740 BAYMEADOW DR. SE DECISION MADE: 30-MAY-07
GLEN BURNIE, MD 21060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPAS SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K070993(SPECIAL)
ATTN: SARAH PETERSON PHONE NO : 952-930-6431
10700 BREN RD., WEST SE DECISION MADE: 09-MAY-07
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBEST HCG PANEL TEST KIT
AMERITEK USA, INC. 510(k) NO: K061257(TRADITIONAL)
ATTN: K C YEE PHONE NO : 425-379-2580
125 130 ST. SE, SE DECISION MADE: 04-MAY-07
#200 510(k) STATEMENT
EVERETT, WA 98208
DEVICE: SYNEPIX 4600 DETECTOR
ANALOGIC CORPORATION 510(k) NO: K070829(ABBREVIATED)
ATTN: DONALD J SHERRATT PHONE NO : 978-977-3000
8 CENTENNIAL DR. SE DECISION MADE: 09-MAY-07
PEABODY, MA 01960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
ANATOMICA AB 510(k) NO: K061943(TRADITIONAL)
ATTN: MARCOS VELEZ-DURAN PHONE NO : 202-546-1262
719 A STREET, NE SE DECISION MADE: 25-MAY-07
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K070615(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 04-MAY-07
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE
APATECH LTD. 510(k) NO: K071206(SPECIAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503-722-7494
15058 ARMEL DRIVE SE DECISION MADE: 31-MAY-07
OREGON CITY, OR 97045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX MEDICAL XT1 CPAP, MODEL 9S-005
APEX MEDICAL CORP. 510(k) NO: K070609(SPECIAL)
ATTN: ALAN CHANG PHONE NO : 886 2 22683100
NO. 9, MINSHENG STREET SE DECISION MADE: 04-MAY-07
TUCHENG CITY, TAIPEI COUNTY, CHINA510(k) STATEMENT
DEVICE: APEX MEDICAL MOBINEB, 9R-027 SERIES
APEX MEDICAL CORP. 510(k) NO: K070990(SPECIAL)
ATTN: ALAN CHANG PHONE NO : 886 222 683100
NO. 9, MINSHENG ST., SE DECISION MADE: 18-MAY-07
TU-CHENG 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 236
DEVICE: ARAGON SURGICAL LAPCAP
ARAGON SURGICAL INC. 510(k) NO: K070651(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 650-543-3107
1810 EMBARCADERO ROAD, SUITE B SE DECISION MADE: 30-MAY-07
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED LIGASURE VESSEL SEALER/DIVIDER
ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K062525(TRADITIONAL)
ATTN: MOIRA BARTON PHONE NO : 480-763-5350
10232 SOUTH 51ST ST. SE DECISION MADE: 16-MAY-07
PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERWORKS
AVREO, INC. 510(k) NO: K070755(TRADITIONAL)
ATTN: NANCY BUTCHER PHONE NO : 214-244-1798
4050 AZALEA DR. SE DECISION MADE: 08-MAY-07
N. CHARLESTON, SC 29405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
BARCOVIEW MIS EDINBURGH 510(k) NO: K070831(TRADITIONAL)
ATTN: NEIL PHILLIPS PHONE NO : 013 147 24792
BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 22-MAY-07
EDINBURGH, LOTHIAN, UNITED KINGDOM510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: NIO COLOR 3MP AND MDNC 3120
BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K070726(TRADITIONAL)
ATTN: LIEVEN DE WANDEL PHONE NO : 32 56 233459
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 02-MAY-07
KORTRIJK, BELGIUM B-8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRA PLEURAL DRAINAGE SYSTEM
BARD ACCESS SYSTEMS, INC. 510(k) NO: K071095(TRADITIONAL)
ATTN: JIHYUN KIM PHONE NO : 801-595-7175
5425 WEST AMELIA EARNHART DR. SE DECISION MADE: 18-MAY-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
BAXTER HEALTHCARE CORP. 510(k) NO: K071222(SPECIAL)
ATTN: NANETTE HEDDEN PHONE NO : 847-473-6281
1620 WAUKEGAN ROAD SE DECISION MADE: 25-MAY-07
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CR
BECKMAN COULTER, INC. 510(k) NO: K070626(TRADITIONAL)
ATTN: TARA VIVIANI PHONE NO : 714-961-3626
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 04-MAY-07
BREA, CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOLISA ANTI-HAV EIA
BIO-RAD LABORATORIES 510(k) NO: K063318(TRADITIONAL)
ATTN: MANUELA KAUL PHONE NO : 33 1 47956096
3 BD RAYMOND POINCARE SE DECISION MADE: 03-MAY-07
MARNES-LA-COQUETTE 510(k) SUMMARY AVAILABLE FROM FDA
HAUTS-DE-SEINE, FRANCE 92430
DEVICE: MONOLISA ANTI-HAV IGM EIA
BIO-RAD LABORATORIES 510(k) NO: K063319(TRADITIONAL)
ATTN: MANUELA KAUL PHONE NO : 33 1 47956096
3 BD RAYMOND POINCARE SE DECISION MADE: 03-MAY-07
MARNES-LA-COQUETTE 510(k) SUMMARY AVAILABLE FROM FDA
HAUTS-DE-SEINE, FRANCE 92430
DEVICE: VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
BIO-RAD LABORATORIES, INC. 510(k) NO: K070452(TRADITIONAL)
ATTN: JACKIE H BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR SE DECISION MADE: 07-MAY-07
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BILOK SCREW
BIOCOMPOSITES LTD. 510(k) NO: K071091(SPECIAL)
ATTN: SIMON FITZER PHONE NO : 441 782 338580
KEELE SCIENCE PARK SE DECISION MADE: 17-MAY-07
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BILOK ST SCREW
BIOCOMPOSITES LTD. 510(k) NO: K071115(SPECIAL)
ATTN: SIMON FITZER PHONE NO : 441 782 338580
KEELE SCIENCE PARK SE DECISION MADE: 17-MAY-07
KEELE, STAFFORDSHIRE, UNITED KINGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM
BIOINFERA, INC. 510(k) NO: K061323(TRADITIONAL)
ATTN: CHAN Q WANG PHONE NO : 216-226-2880
23230 CHAGRIN BLVD. SE DECISION MADE: 23-MAY-07
SUITE # 950 510(k) SUMMARY AVAILABLE FROM FDA
BEACHWOOD, OH 44122
DEVICE: 100W CERALAS D 980NM DIODE LASER
BIOLITEC, INC. 510(k) NO: K071295(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 16-MAY-07
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTAPLE, OSSPLATE, OSSFORCE
BIOMEDICAL ENTERPRISES, INC 510(k) NO: K061385(TRADITIONAL)
ATTN: W. CASEY FOX PHONE NO : 210-677-0354
14785 OMICRON DR STE 205 SE DECISION MADE: 30-MAY-07
SAN ANTONIO, TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERGRO ORAL
BIOMET 3I 510(k) NO: K070147(TRADITIONAL)
ATTN: TAMARA J NELSON PHONE NO : 561-776-6923
4555 RIVERSIDE DRIVE SE DECISION MADE: 14-MAY-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
BIOMET MANUFACTURING, INC. 510(k) NO: K070399(SPECIAL)
ATTN: TRACY B JOHNSON PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 04-MAY-07
WARSAW, IN 46581-0578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GROWTH CONTROL PLATING SYSTEM
BIOMET TRAUMA 510(k) NO: K070823(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
100 INTERFACE PARKWAY SE DECISION MADE: 07-MAY-07
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 100KGY E-POLY MAXROM ACETABULAR LINERS
BIOMET, INC. 510(k) NO: K070364(SPECIAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 03-MAY-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO XP EP NAVIGATION SYSTEM, VERSION 9
BIOSENSE WEBSTER, INC. 510(k) NO: K070240(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 909-839-7391
3333 DIAMOND CANYON RD. SE DECISION MADE: 04-MAY-07
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
BIOSENSE WEBSTER, INC. 510(k) NO: K070242(TRADITIONAL)
ATTN: NEELU MEDHEKAR PHONE NO : 909-839-7391
3333 DIAMOND CANYON RD. SE DECISION MADE: 15-MAY-07
DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPC-BOOT
C-BOOT LTD. 510(k) NO: K070324(SPECIAL)
ATTN: AVI ABRAHAM PHONE NO : 972 504 949699
8 MARVA STREET SE DECISION MADE: 03-MAY-07
CARMIEL, ISRAEL 21691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
C.R. BARD, INC. 510(k) NO: K070996(SPECIAL)
ATTN: LYNN M KIRCHOFF PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 08-MAY-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
C.R. BARD, INC. 510(k) NO: K071204(SPECIAL)
ATTN: KIMBERLY GEISLER PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 18-MAY-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYGUARD PAIN MANAGER INFUSION SYSTEM
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K070235(SPECIAL)
ATTN: SHLOMI DINES PHONE NO : 972 462 74737
16 SHACHAM STREET SE DECISION MADE: 18-MAY-07
INDUSTRIAL PARK 510(k) STATEMENT
CAESAREA, ISRAEL 38900
DEVICE: ASCENT DENTAL CLEANSER
CAO GROUP, INC. 510(k) NO: K070070(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801-256-9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 25-MAY-07
WEST JORDAN, UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEXIUM SYRINGE
CARDINAL HEALTH, ALARIS PRODUCTS 510(k) NO: K071108(TRADITIONAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIRCLE SE DECISION MADE: 24-MAY-07
SAN DIEGO, CA 92121-2772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHAD THERAPEUTICS BONSAI MODEL 800
CHAD THERAPEUTICS, INC. 510(k) NO: K070740(SPECIAL)
ATTN: KEVIN MCCULLOH PHONE NO : 818-882-0883
21622 PLUMMER ST. SE DECISION MADE: 07-MAY-07
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
CHI LIN TECHNOLOGY CO., LTD. 510(k) NO: K063269(TRADITIONAL)
ATTN: JUDY LIN PHONE NO : 886 2 26006368
3F, # 86, SEC 1 WUNHUA 1ST RD. SE DECISION MADE: 23-MAY-07
LINKUO, TAIPEI HSIEN, CHINA (TAIWA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
CHURCH & DWIGHT CO., INC. 510(k) NO: K070054(TRADITIONAL)
ATTN: CYNTHIA DAVIDSON PHONE NO : 609-497-7479
469 NORTH HARRISON STREET SE DECISION MADE: 04-MAY-07
PRINCETON, NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSPONGE SYSTEM
CLEARCOUNT MEDICAL SOLUTIONS, INC.510(k) NO: K071355(TRADITIONAL)
ATTN: STEVEN FLECK PHONE NO : 412-322-4110
700 RIVER AVE., SUITE 100 SE DECISION MADE: 24-MAY-07
PITTSBURGH, PA 15212 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTRO
CLINIQA CORPORATION 510(k) NO: K070741(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 04-MAY-07
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR
CONFLUENT SURGICAL,INC 510(k) NO: K070814(SPECIAL)
ATTN: KRISTINE BURKE PHONE NO : 781-839-1738
101A FIRST AVE. SE DECISION MADE: 30-MAY-07
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS.
CONTAMAC LTD. 510(k) NO: K070628(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
2214 SANFORD DRIVE,SUITE B7 SE DECISION MADE: 01-MAY-07
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESONANCE METALLIC URETERAL STENT
COOK IRELAND LTD 510(k) NO: K063742(TRADITIONAL)
ATTN: SINEAD BURKE PHONE NO : 003 536 1334440
O'HALLORAN ROAD SE DECISION MADE: 08-MAY-07
NATIONAL TECHNOLOGY PARK 510(k) SUMMARY AVAILABLE FROM FDA
LIMERICK, IRELAND
DEVICE: CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
CORDIS EUROPA, N.V. 510(k) NO: K071189(SPECIAL)
ATTN: HARM HOVINGA PHONE NO : 31 505 022479
OOSTEINDE 8 SE DECISION MADE: 16-MAY-07
RODEN, NETHERLANDS NL-9301 LJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
CORGENIX, INC. 510(k) NO: K062025(TRADITIONAL)
ATTN: KIMBERLY N HASSLER PHONE NO : 303-457-4345
11575 MAIN ST. SE DECISION MADE: 29-MAY-07
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80020
DEVICE: CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500
CSA MEDICAL, INC. 510(k) NO: K070893(SPECIAL)
ATTN: JENNIFER CARTLEDGE PHONE NO : 443-921-8053
1101 E. 33RD STREET SE DECISION MADE: 01-MAY-07
THIRD FLOOR - #A305 510(k) SUMMARY AVAILABLE FROM FDA
BALTIMORE, MD 21218
DEVICE: CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
CUSTOM SCIENTIFIC 510(k) NO: K062572(TRADITIONAL)
ATTN: PATSY J TRISLER PHONE NO : 301-652-5344
5600 WISCONSIN AVE, # 509 SE DECISION MADE: 11-MAY-07
CHEVY CHASE, MD 20815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLI
DADE BEHRING, INC. 510(k) NO: K070860(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
1584 ENTERPRISE BLVD. SE DECISION MADE: 11-MAY-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
DADE BEHRING, INC. 510(k) NO: K071076(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 21-MAY-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFF (MARK I) VOLUMETRIC INFUSION PUMP
DEFINITIVE MEDICAL TECHNOLOGIES, L510(k) NO: K070529(TRADITIONAL)
ATTN: BOAZ BARTOV PHONE NO : 972 892 51171
4 HAMELACHA ST. SE DECISION MADE: 08-MAY-07
NORTH INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
LOD, ISRAEL 71520 THIRD PARTY REVIEW
DEVICE: GASTROSTOMY REPLACEMENT TUBE, MODEL 253
DEGANIA SILICONE, LTD. 510(k) NO: K070124(TRADITIONAL)
ATTN: ZOYA LEE PHONE NO : 972 467 0533
DEGANIA BET SE DECISION MADE: 23-MAY-07
EMEK HAYARDEN, ISRAEL 15130 510(k) STATEMENT
DEVICE: AURAVUE PIT & FISSURE SEALANT
DENALI CORPORATION 510(k) NO: K070693(TRADITIONAL)
ATTN: JAN G STANNARD PHONE NO : 781-826-9190
134 OLD WASHINGTON STREET SE DECISION MADE: 09-MAY-07
HANOVER, MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION RESIN CEMENT AND CORE KIT
DENALI CORPORATION 510(k) NO: K070702(TRADITIONAL)
ATTN: JAN G STANNARD PHONE NO : 781-826-9190
134 OLD WASHINGTON STREET SE DECISION MADE: 10-MAY-07
HANOVER, MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K070307(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST., SE 60 SE DECISION MADE: 02-MAY-07
SUSQUEHANNA COMMERCE CTR. 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K070925(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359
325 PARAMOUNT DR. SE DECISION MADE: 02-MAY-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071117(SPECIAL)
ATTN: NATALIE HECK PHONE NO : 574-371-4906
700 ORTHOPAEDIC DR. SE DECISION MADE: 18-MAY-07
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY CI HIP INSTRUMENTATION
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K071135(SPECIAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 23-MAY-07
P.O BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K070994(SPECIAL)
ATTN: FRANK S JURCZAK PHONE NO : 508-828-3288
325 PARAMOUNT DR. SE DECISION MADE: 09-MAY-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIO PROTEM IMPLANT SYSTEM
DIO DEPARTMENT DSI, INC. 510(k) NO: K070568(TRADITIONAL)
ATTN: KENNY LIM PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD SE DECISION MADE: 25-MAY-07
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: MEDILAS D FAMILY LASERS
DORNIER MEDTECH AMERICA, INC. 510(k) NO: K070536(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 770-514-6163
1155 ROBERTS BLVD. SE DECISION MADE: 21-MAY-07
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
DUKAL CORPORATION 510(k) NO: K070692(TRADITIONAL)
ATTN: PATRICK J LAMB PHONE NO : 631-656-3800
5 PLANT AVENUE SE DECISION MADE: 30-MAY-07
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUPULSE PULSE OXIMETER
EAGLE MEDICAL EQUIPMENT CO. 510(k) NO: K062724(TRADITIONAL)
ATTN: JAMES A DUNNING PHONE NO : 480-703-3631
537 N SPENCER SE DECISION MADE: 11-MAY-07
MESA, AZ 85203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUPEL TRANSPORT IONTOPHORESIS SYSTEM
EMPI 510(k) NO: K070427(TRADITIONAL)
ATTN: SANDRA WALROD PHONE NO : 651-415-7344
599 CARDIGAN RD. SE DECISION MADE: 14-MAY-07
ST. PAUL, MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALITY HIP SYSTEM MODEL#420
ENCORE MEDICAL, L.P. 510(k) NO: K070050(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6225
9800 METRIC BLVD. SE DECISION MADE: 23-MAY-07
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
ENVITEC-WISMAR GMBH 510(k) NO: K070193(TRADITIONAL)
ATTN: STEPHEN GORSKI PHONE NO : 262-594-2114
S65 W35739 PIPER ROAD SE DECISION MADE: 02-MAY-07
EAGLE, WI 53119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIEWMATE SYSTEM
EP MEDSYSTEMS 510(k) NO: K071028(SPECIAL)
ATTN: LARRY PICCIANO PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 01-MAY-07
575 ROUTE 73 N. BLDG. D 510(k) SUMMARY AVAILABLE FROM FDA
WEST BERLIN, NJ 08091
DEVICE: EPI-C PLUS
ESPANSIONE MARKETING SPA 510(k) NO: K070494(TRADITIONAL)
ATTN: GUIDO BONAPACE PHONE NO : 39 051 6257315
VIA CALINDRI, 50 SE DECISION MADE: 01-MAY-07
SAN LAZZARO DI SAVENA (BO), ITALY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LI
ETHICON ENDO-SURGERY, LLC 510(k) NO: K070887(TRADITIONAL)
ATTN: DENNIS HAHN PHONE NO : 513-337-3134
4545 CREEK ROAD SE DECISION MADE: 25-MAY-07
CINCINNATI, OH 45242 510(k) STATEMENT
DEVICE: EUROIMMUN ANA IFA: HEP-20-10
EUROIMMUN US LLC 510(k) NO: K070763(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-402-6101
429 ROCKAWAY VALLEY ROAD SE DECISION MADE: 22-MAY-07
UNIT 1200 510(k) STATEMENT
BOONTON TOWNSHIP, NJ 07005
DEVICE: MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
EXIR PHARMACEUTICAL CO. 510(k) NO: K070239(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F,NO.88,SEC. 1,KWANG-FU RD., SE DECISION MADE: 25-MAY-07
SAN-CHUNG 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI,COUNTY, CHINA (TAIWAN) 241
DEVICE: FEMTEN CERVICAL TENACULUM
FEM SUITE, L.L.C. 510(k) NO: K062563(TRADITIONAL)
ATTN: CARL YOUNGMANN PHONE NO : 360-379-3660
1530 HOLCOMB STREET SE DECISION MADE: 18-MAY-07
PORT TOWNSEND, WA 98368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
FLEXICATH LTD. 510(k) NO: K063363(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATAAS STR. SE DECISION MADE: 07-MAY-07
P.O.B. 124 510(k) SUMMARY AVAILABLE FROM FDA
KFAR SABA, ISRAEL 44425
DEVICE: FUJI IP CASSETTE TYPE PC
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K070920(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 203-602-3774
419 WEST AVE. SE DECISION MADE: 22-MAY-07
STAMFORD, CT 06902-6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAGWIRE SYSTEM
FXDEVICES 510(k) NO: K070393(TRADITIONAL)
ATTN: RICH LIPSCHUTZ PHONE NO : 561-394-6501
ONE SOUTH OCEAN BLVD. SE DECISION MADE: 04-MAY-07
BOCA RATON, FL 33432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GVC-100
GC AMERICA, INC. 510(k) NO: K070840(TRADITIONAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 15-MAY-07
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K071073(SPECIAL)
ATTN: KAREN M LUNDE PHONE NO : 414-362-3172
8200 WEST TOWER AVE. SE DECISION MADE: 11-MAY-07
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOMEM CM 3000-12BT
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K063042(SPECIAL)
ATTN: SID MATHUR PHONE NO : 516-482-9001
55 NORTHERN BLVD SE DECISION MADE: 30-MAY-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K070475(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 403 208 4916
91 ROCKYSPRING CIRCLE NW SE DECISION MADE: 07-MAY-07
CALGARY, ALBERTA, CANADA T3G 6A1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HA
HANSEN MEDICAL, INC. 510(k) NO: K052480(TRADITIONAL)
ATTN: NINA PELED PHONE NO : 650-404-5834
380 NORTH BERNARDO AVE. SE DECISION MADE: 02-MAY-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONARCH NASAL IMPLANT
HANSON MEDICAL, INC. 510(k) NO: K071018(TRADITIONAL)
ATTN: GERALD HANSON PHONE NO : 360-297-1997
P.O. BOX 1160 SE DECISION MADE: 25-MAY-07
KINGSTON, WA 98346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K071005(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 22-MAY-07
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K071006(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 21-MAY-07
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACKRECORD DATA MANAGEMENT SOFTWARE
HOME DIAGNOSTICS, INC. 510(k) NO: K070593(TRADITIONAL)
ATTN: KAREN DEVINCENT PHONE NO : 954-677-9201
2400 N.W. 55TH CT. SE DECISION MADE: 07-MAY-07
FORT LAUDERDALE, FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
HONG XIN RUBBER PRODUCTS CO., LTD 510(k) NO: K070861(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAFER AVE. SE DECISION MADE: 15-MAY-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOX MEDICAL DIODE LASER SYSTEM 810NM
HOWARD INSTRUMENTS, INC. 510(k) NO: K063104(TRADITIONAL)
ATTN: JACK HOWARD PHONE NO : 205-553-4453
4749 APPLETREE LN. SE DECISION MADE: 16-MAY-07
TUSCALOOSA, AL 35405-5747 510(k) STATEMENT
DEVICE: UNIVERSAL TAPER DELTA FEMORAL HEAD
HOWMEDICA OSTEONICS CORP 510(k) NO: K070885(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 16-MAY-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUNION HA FRACTURE STEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K070963(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 04-MAY-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURACON X3 CS TIBIAL INSERT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K070883(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DRIVE SE DECISION MADE: 11-MAY-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASNIS MICRO CANNULATED SCREW
HOWMEDICA OSTEONICS CORP. 510(k) NO: K071092(SPECIAL)
ATTN: VIVIAN KELLY PHONE NO : 201-831-5581
325 CORPORATE DRIVE SE DECISION MADE: 11-MAY-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
IDAHO TECHNOLOGY, INC. 510(k) NO: K071188(SPECIAL)
ATTN: BETH LINGENFELTER PHONE NO : 801-736-6354
390 WAKARA WAY SE DECISION MADE: 21-MAY-07
SALT LAKE CITY, UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURO II-SE, MODELS: OR-DR-OR, OR-MB
IMRIS, INC. 510(k) NO: K071099(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 22-MAY-07
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMM HYPODERMIC NEEDLE SET
INNOVATIVE MEDICAL MANUFACTURING C510(k) NO: K070801(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 832-545-8399
7128 STAFFORDSHIRE ST. SE DECISION MADE: 24-MAY-07
HOUSTON, TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANTLIA I WOUND IRRIGATION SYSTEM
INNOVATIVE THERAPIES, INC. 510(k) NO: K071301(TRADITIONAL)
ATTN: JUDITH HARBOUR PHONE NO : 210-363-5216
11 VENDUE COURT SE DECISION MADE: 24-MAY-07
SIMPSONVILLE, SC 29681 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IOS EXTERNAL FIXATOR, MODEL 2-0-0
INTELLIGENT ORTHOPAEDICS LTD 510(k) NO: K070724(TRADITIONAL)
ATTN: NEIL MCLACHLAN PHONE NO : 441 282 895199
BRIERFIELD MILL SE DECISION MADE: 16-MAY-07
BRIERFIELD, NELSON, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AN
INTERNATIONAL BUSINESS STRATEGIES 510(k) NO: K062149(TRADITIONAL)
ATTN: BILL ROETTGER PHONE NO : 843-224-0553
1667A MARSH HABOR LN. SE DECISION MADE: 31-MAY-07
MOUNT PLEASANT, SC 29464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYRIAN
INTRASENSE 510(k) NO: K071000(TRADITIONAL)
ATTN: NICOLAS CLARY PHONE NO : 33 567 731739
BAT B-99, ROUTE D'ESPAGNE SE DECISION MADE: 14-MAY-07
LES PORTES D'ESPAGNE 510(k) SUMMARY AVAILABLE FROM FDA
TOULOSE, FRANCE 31100
DEVICE: ADHESE ONE
IVOCLAR VIVADENT, INC. 510(k) NO: K070646(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 11-MAY-07
AMHERST, NY 14228 510(k) STATEMENT
DEVICE: LUBRINA, MODEL HIM-1
J. MORITA USA, INC. 510(k) NO: K070074(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 31-MAY-07
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
JMS NORTH AMERICA CORP. 510(k) NO: K070234(SPECIAL)
ATTN: SWEE CHEAU CHONG PHONE NO : 510-888-9090
22320 FOOTHILL BLVD., SE DECISION MADE: 22-MAY-07
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
HAYWARD, CA 94541
DEVICE: RANGE SPINAL SYSTEM
K2M, INC. 510(k) NO: K070229(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 03-MAY-07
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
KAREX INDUSTRIES SDN BHD 510(k) NO: K070830(ABBREVIATED)
ATTN: LENG KIAN GOH PHONE NO : 607 688 1996
PTD. 7906/7907, TAMAN PONTIAN SE DECISION MADE: 08-MAY-07
JAYA, BT. 34, JALAN JOHOR 510(k) SUMMARY AVAILABLE FROM FDA
PONTIAN, JOHOR, MALAYSIA 82000
DEVICE: IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K070716(SPECIAL)
ATTN: PAUL S LEE PHONE NO : 310-410-2769
600 CORPORATE POINTE SE DECISION MADE: 31-MAY-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KSEA MINIATURE ENDOSCOPE, MODEL 11565
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K070752(TRADITIONAL)
ATTN: CRYSTAL K DIZOL PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 01-MAY-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K070827(TRADITIONAL)
ATTN: SUSIE CHEN PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 22-MAY-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KELSEY INTERSITITAL LASER THERAPY SYSTEM
KELSEY, INC. 510(k) NO: K070353(TRADITIONAL)
ATTN: PAUL KETTERIDGE PHONE NO : 443-729-0836
303 PATLEIGH RD SE DECISION MADE: 02-MAY-07
CATONSVILLE, MD 21228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT DIGITIZER, REGIUS MODEL 110
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K071181(SPECIAL)
ATTN: RUSSEL MUNVES PHONE NO : 212-490-4100
140 EAST 45TH ST., 25TH FLOOR SE DECISION MADE: 30-MAY-07
TWO GRAND CENTRAL TOWER 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10017
DEVICE: KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
KOREAMEDICO CO. LTD. 510(k) NO: K062096(TRADITIONAL)
ATTN: KIM YOUNG-YONG PHONE NO : 82 2 26425980
2F, 839-9 HWAGOK-4-DONG, SE DECISION MADE: 07-MAY-07
GANGSEO-GU 510(k) STATEMENT
SEOUL, REPUBLIC OF KOREA 157-902
DEVICE: FLEX ARM RETRACTOR SYSTEM
KOROS USA, INC. 510(k) NO: K071338(TRADITIONAL)
ATTN: GABRIEL KOROS PHONE NO : 805-529-0825
610 FLINN AVE. SE DECISION MADE: 29-MAY-07
MOORPARK, CA 93021 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
LABORIE MEDICAL TECHNOLOGIES 510(k) NO: K070331(TRADITIONAL)
ATTN: BARBARA MORNET PHONE NO : 802-857-1300
400 AVENUE D SUITE 10 SE DECISION MADE: 04-MAY-07
WILLISTON, VT 05495 510(k) STATEMENT
DEVICE: LENSTEC LC INJECTION SYSTEM
LENSTEC, INC. 510(k) NO: K063802(TRADITIONAL)
ATTN: JIMMY CHACKO PHONE NO : 727-571-2272
2870 SCHERER DR., SUITE 300 SE DECISION MADE: 07-MAY-07
ST. PETERSBURG, FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHT RELIEF, MODEL LR150, LR200
LIGHT RELIEF, LLC 510(k) NO: K070974(SPECIAL)
ATTN: LAURIE MCLAUGHLIN PHONE NO : 323-202-1557
4929 WILSHIRE BLVD., STE. 500 SE DECISION MADE: 24-MAY-07
LOS ANGELES, CA 90010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
LITTLE DOCTOR (SHANGHAI) ELECTRONI510(k) NO: K070825(TRADITIONAL)
ATTN: DAVID ZHANG PHONE NO : 008 602 163056696
ROOM C,FLOOR 22, ZHIYUAN BLDG SE DECISION MADE: 25-MAY-07
NO. 768 XIETU ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 20023
DEVICE: EDAC QUANTIFIER
LUNA INNOVATIONS, INC. 510(k) NO: K071231(TRADITIONAL)
ATTN: KRISTINE RICHARDSON PHONE NO : 540-552-5128
3157 STATE STREET SE DECISION MADE: 17-MAY-07
BLACKSBURG, VA 24060 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MP 719
MARINE POLYMER TECHNOLOGIES, INC. 510(k) NO: K070557(TRADITIONAL)
ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781-270-3200
461 BOSTON ST., UNIT B5 SE DECISION MADE: 23-MAY-07
TOPSFIELD, MA 01983 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (
MEDCOMP 510(k) NO: K070003(TRADITIONAL)
ATTN: JEAN CALLOW PHONE NO : 215-256-4201
1499 DELP DR. SE DECISION MADE: 15-MAY-07
HARLEYSVILLE, PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LMS-LUNG/TRACK
MEDIAN TECHNOLOGIES 510(k) NO: K070868(TRADITIONAL)
ATTN: CHAS BURR PHONE NO : 781-789-1646
11 MYSTIC AVE. SE DECISION MADE: 15-MAY-07
WINCHESTER, MA 01890-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL
MEDTEXX MANUFACTURING SDN. BHD. 510(k) NO: K070821(TRADITIONAL)
ATTN: OOI LOON SENG PHONE NO : 605 891 1111
PT 4004 KAMUNTING INDU. ESTATE SE DECISION MADE: 10-MAY-07
KAMUNTING, TAIPING, PERAK, MALAYSI510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-CONSOLE, MODEL 560
MEDTRONIC 510(k) NO: K070286(TRADITIONAL)
ATTN: CHERYL NORTON PHONE NO : 763-391-9532
7611 NORTHLAND DRIVE SE DECISION MADE: 22-MAY-07
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCUATE VERTEBRAL AUGMENTATION SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K070527(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 04-MAY-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ PLUS IMPLANT SYSTEM
MEGAGEN CO., LTD. 510(k) NO: K070562(TRADITIONAL)
ATTN: DAE K CHANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 18-MAY-07
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: METASURG SUBTALAR IMPLANT
METASURG 510(k) NO: K070441(TRADITIONAL)
ATTN: LARRY WEATHERFORD PHONE NO : 281-398-5656
16350 PARK TEN PL., SUITE 101 SE DECISION MADE: 08-MAY-07
HOUSTON, TX 77084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS COURIER ENZO MICROCATHETER 0.017
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K070456(SPECIAL)
ATTN: R. MICHAEL CROMPTON PHONE NO : 650-678-7593
821 FOX LANE SE DECISION MADE: 24-MAY-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
MISONIX, INC. 510(k) NO: K070313(SPECIAL)
ATTN: RONALD R MANNA PHONE NO : 631-694-9555
1938 NEW HIGHWAY SE DECISION MADE: 11-MAY-07
FARMINGDALE, NY 11735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOFIX PUSH-IN ANCHOR
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K070347(TRADITIONAL)
ATTN: NANCY L BENNEWITZ PHONE NO : 732-661-0202
125 MAY STREET SE DECISION MADE: 11-MAY-07
EDISON, NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASONIC SCALER, VARIOS 560
NAKANISHI, INC. 510(k) NO: K062731(TRADITIONAL)
ATTN: NORIMASA KANEKO PHONE NO : 028 964 3380
700 SHIMOHINATA SE DECISION MADE: 01-MAY-07
KANUMA-SHI, TOCHIGI-KEN, JAPAN 322510(k) STATEMENT
DEVICE: PANOSOL II TRU-BLU, MODEL UBL-417
NATIONAL BIOLOGICAL CORP. 510(k) NO: K070934(TRADITIONAL)
ATTN: GEORGE KRINER PHONE NO : 330-425-3535
1532 ENTERPRISE PKWY. SE DECISION MADE: 22-MAY-07
TWINSBURG, OH 44087 510(k) STATEMENT
DEVICE: DURAMAX REUSABLE OXIMETRY SENSOR
NELLCOR PURITAN BENNETT, INC. 510(k) NO: K070408(ABBREVIATED)
ATTN: JAMES BONDS PHONE NO : 925-463-4479
4280 HACIENDA DR. SE DECISION MADE: 25-MAY-07
PLEASANTON, CA 94588-2719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
NEOCOIL 510(k) NO: K071311(TRADITIONAL)
ATTN: BRIAN BROWN PHONE NO : 262-347-1250
N27 W23910A PAUL RD. SE DECISION MADE: 22-MAY-07
PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
NEOFORCE GROUP, INC. 510(k) NO: K070416(TRADITIONAL)
ATTN: MARY STANIEWICZ PHONE NO : 215-672-6800
35 COMMERCE DR. SE DECISION MADE: 29-MAY-07
IVYLAND, PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYSMITH SLEEP SYSTEM, MODEL NTI5498
NEUROTRONICS, INC. 510(k) NO: K062943(TRADITIONAL)
ATTN: JENNIFER LAINE PHONE NO : 352-372-9955
102 N.E. 10TH AVE., SUITE 5 SE DECISION MADE: 09-MAY-07
GAINESVILLE, FL 32601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERSTAR 0.35T MRI SYSTEM
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K071154(TRADITIONAL)
ATTN: PHONE NO :
NO.3-11, WENHUA ROAD SE DECISION MADE: 10-MAY-07
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
NEW BAY BIORESEARCH CO. LTD. 510(k) NO: K063693(TRADITIONAL)
ATTN: RODRIGO BERLIE PHONE NO : 760-828-0990
3108 AVENIDA OLMEDA SE DECISION MADE: 11-MAY-07
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXFIX COMPRESSION STAPLE
NEXA ORTHOPEDICS, INC. 510(k) NO: K070688(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-866-0660
11035 ROSELLE STREET SE DECISION MADE: 18-MAY-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTACT LENS CASE
NINGBO KAIDA RUBBER AND PLASTIC TE510(k) NO: K071081(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 86 21 64264467
LANE 999, ZHONGSHAN NO. 2 ROAD SE DECISION MADE: 01-MAY-07
SUITE 8D, ZHONGXIN ZHONGSHAN B 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030 THIRD PARTY REVIEW
DEVICE: LIFESENSE, MODEL LS1-9R
NONIN MEDICAL, INC. 510(k) NO: K063752(TRADITIONAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 04-MAY-07
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL PULSE OXIMETER, MODEL 7500FO
NONIN MEDICAL, INC. 510(k) NO: K071415(TRADITIONAL)
ATTN: LORI M ROTH PHONE NO : 763-577-3093
13700 1ST AVE. NORTH SE DECISION MADE: 25-MAY-07
PLYMOUTH, MN 55441-5443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO DETECT FOR TELAHEART DR200/E-A
NORTHEAST MONITORING, INC. 510(k) NO: K070014(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 25-MAY-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LIN
NOVA BIOMEDICAL CORP. 510(k) NO: K070068(TRADITIONAL)
ATTN: PAUL W MACDONALD,PHD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 07-MAY-07
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K071037(SPECIAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822
2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 10-MAY-07
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
NOVAMIN TECHNOLOGY, INC. 510(k) NO: K071267(SPECIAL)
ATTN: ROBERT G ROTHFRITZ PHONE NO : 386-418-1551
13709 PROGRESS BLVD., STE. 23 SE DECISION MADE: 18-MAY-07
ALACHUA, FL 32615 510(k) STATEMENT
DEVICE: NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
NUNC A/S 510(k) NO: K070047(TRADITIONAL)
ATTN: JANA S HELLMANN PHONE NO : 45 463 12154
KAMSTRUPUEJ 90, KAMSTRUP SE DECISION MADE: 18-MAY-07
ROSKILDE, DENMARK DK-4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURAT
OMEGA MEDICAL IMAGING, INC. 510(k) NO: K070834(TRADITIONAL)
ATTN: JAMES A PRINCEHORN PHONE NO : 407-323-9400
675 HICKMAN CIRCLE SE DECISION MADE: 18-MAY-07
SANFORD, FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVICEL APPLICATION DEVICE
OMRIX BIOPHARMACEUTICALS LTD. 510(k) NO: K070575(TRADITIONAL)
ATTN: DAVID NAKAR PHONE NO : 972 8 9437519
MDA BLOOD BANK SE DECISION MADE: 29-MAY-07
SHEBA HOSPITAL, TEL HASHOMER 510(k) STATEMENT
RAMAT GAN, ISRAEL 52621
DEVICE: COLIN PRESS MATE, MODEL BP S510
OMRON HEALTHCARE, INC. 510(k) NO: K063690(SPECIAL)
ATTN: RANNDY KELLOGG PHONE NO : 847-247-5609
1200 LAKESIDE DRIVE SE DECISION MADE: 09-MAY-07
BANNOCKBURN, IL 60015 510(k) STATEMENT
DEVICE: POGS, MODEL 33C
ON SITE GAS SYSTEMS, INC. 510(k) NO: K063454(TRADITIONAL)
ATTN: GUY HATCH PHONE NO : 860-667-8888
35 BUDNEY RD. SE DECISION MADE: 09-MAY-07
NEWINGTON, CT 06111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES
ORTHO DEVELOPMENT CORP. 510(k) NO: K062171(TRADITIONAL)
ATTN: JOHANNE YOUNG PHONE NO : 801-619-3470
12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 25-MAY-07
DRAPER, UT 84020 510(k) STATEMENT
DEVICE: VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K071215(SPECIAL)
ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143
100 INDIGO CREEK DR. SE DECISION MADE: 25-MAY-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K071216(SPECIAL)
ATTN: MICHAEL M BYRNE PHONE NO : 585-453-3143
100 INDIGO CREEK DR. SE DECISION MADE: 25-MAY-07
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: METAL HEMI IMPLANT
ORTHOPRO LLC 510(k) NO: K071243(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 23-MAY-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL
OSSUR AMERICANS (FORMERLY THE JERO510(k) NO: K071173(SPECIAL)
ATTN: BERNIE TATRO PHONE NO : 856-345-6019
1414 METROPOLITAN AVENUE SE DECISION MADE: 25-MAY-07
PAULSBORO, NJ 08066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTIAL PRO STENT POSITIONING SYSTEM
OSTIAL SOLUTIONS, LLC 510(k) NO: K062192(TRADITIONAL)
ATTN: MICHAEL J BILLIG PHONE NO : 408-400-0856
155 MOFFETT PARK DRIVE SE DECISION MADE: 24-MAY-07
SUITE A-101 510(k) SUMMARY AVAILABLE FROM FDA
SUNNYVALE, CA 94089
DEVICE: SKIPPI POWERED WHEELCHAIR FOR CHILDREN
OTTO BOCK HEALTHCARE, LP 510(k) NO: K070318(TRADITIONAL)
ATTN: SHANNON TUFVANDER PHONE NO : 763-253-5607
2 CARLSON PKWY. N., SUITE 100 SE DECISION MADE: 11-MAY-07
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR ERBIUM HANDPIECE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K071152(SPECIAL)
ATTN: SHARON TIMBERLAKE, RAC, CCRPHONE NO : 781-993-2414
82 CAMBRIDGE ST. SE DECISION MADE: 25-MAY-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN
PARAGON VISION SCIENCES 510(k) NO: K070637(TRADITIONAL)
ATTN: WILLIAM E MEYERS PHONE NO : 480-507-7606
947 EAST IMPALA AVE. SE DECISION MADE: 01-MAY-07
MESA, AZ 85204 510(k) STATEMENT
DEVICE: ORTHADAPT BIOIMPLANT
PEGASUS BIOLOGICS, INC. 510(k) NO: K071065(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 949-502-3240
6 JENNER SE DECISION MADE: 04-MAY-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTROD
PEPIN MFG., INC. 510(k) NO: K070807(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 23-MAY-07
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHARMASMART PUBLIC USE BLOOD PRESSURE MONITOR, MODELS PS-1000/PS
PHARMASMART, INC. 510(k) NO: K063137(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 727-797-4727
2519 MCMULLEN BOOTH RD. SE DECISION MADE: 01-MAY-07
SUITE 510-295 510(k) SUMMARY AVAILABLE FROM FDA
CLEARWATER, FL 33761
DEVICE: NASOPORE EAR
POLYGANICS BV 510(k) NO: K070715(TRADITIONAL)
ATTN: JAN NIEUWENHUIS PHONE NO : 315 058 86588
L.J. ZIELSTRAWEG 1 SE DECISION MADE: 07-MAY-07
GRONINGEN, NETHERLANDS 9713-GX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FETCH ASPIRATION CATHETER
POSSIS MEDICAL, INC. 510(k) NO: K070363(TRADITIONAL)
ATTN: FRANK B FREEDMAN PHONE NO : 763-717-1013
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 11-MAY-07
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMP
PRO-MED INSTRUMENTS GMBH 510(k) NO: K063494(TRADITIONAL)
ATTN: EDGAR SCHUELE PHONE NO : 239-396-2310
5450 LEE ST, STE 1 SE DECISION MADE: 21-MAY-07
LEHIGH ACRES, FL 33971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO B
PRO-MED INSTRUMENTS GMBH 510(k) NO: K070997(TRADITIONAL)
ATTN: EDGAR SCHUELE PHONE NO : 239-369-2310
5450 LEE ST, STE 1 SE DECISION MADE: 16-MAY-07
LEHIGH ACRES, FL 33971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRODERMA LIQUID BANDAGE
PROCUREMENT TECHNOLOGY SYSTEMS, LL510(k) NO: K063202(TRADITIONAL)
ATTN: WILLIAM J GRISWOLD PHONE NO : 864-655-3500
2375 HIGHWAY 101 SOUTH SE DECISION MADE: 02-MAY-07
BLDG A 510(k) SUMMARY AVAILABLE FROM FDA
GREER, SC 29651
DEVICE: MODEL PMT850
PROMEDTEK, INC. 510(k) NO: K070931(TRADITIONAL)
ATTN: DIANE MANDELL PHONE NO : 703-242-0027
1220 19TH ST., NW SE DECISION MADE: 24-MAY-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20036
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
PURTECH CLEANROOM PRODUCTS CO., LT510(k) NO: K070862(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 30-MAY-07
CHINO, CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
RADIANT MEDICAL 510(k) NO: K071008(TRADITIONAL)
ATTN: SCOTT A WILSON PHONE NO : 650-298-0748
250 CHESAPEAKE DR. SE DECISION MADE: 09-MAY-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN E
REGENERATION TECHNOLOGIES, INC. 510(k) NO: K063584(TRADITIONAL)
ATTN: LISA SIMPSON PHONE NO : 386-418-8888
11621 RESEARCH CIR. SE DECISION MADE: 09-MAY-07
P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32616-2650
DEVICE: FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
RELIANT TECHNOLOGIES, INC. 510(k) NO: K070284(TRADITIONAL)
ATTN: HEATHER MACFALLS PHONE NO : 650-605-2257
464 ELLIS ST. SE DECISION MADE: 17-MAY-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
RENAL SOLUTIONS INC. 510(k) NO: K070739(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-772-6900
770 COMMONWEALTH DRIVE SE DECISION MADE: 25-MAY-07
SUITE 101 510(k) STATEMENT
WARRENDALE, PA 15086
DEVICE: RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20
RENU MEDICAL, INC. 510(k) NO: K063661(TRADITIONAL)
ATTN: BRUCE PIERSON PHONE NO : 425-353-1110
9800 EVERGREEN WAY SE DECISION MADE: 25-MAY-07
EVERETT, WA 98204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALLABY 4
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K070180(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 18-MAY-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP SYNCHRONY WITH AVAPS
RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K070328(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 08-MAY-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COAGUCHEK XS PLUS SYSTEM
ROCHE DIAGNOSTICS 510(k) NO: K071041(SPECIAL)
ATTN: THERESA BUSH PHONE NO : 317-521-3723
9115 HAGUE ROAD SE DECISION MADE: 11-MAY-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK SMART PIX
ROCHE DIAGNOSTICS CORP. 510(k) NO: K062395(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 317-521-3362
9115 HAGUE RD. SE DECISION MADE: 09-MAY-07
INDIANAPOLIS, IN 46256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCU-CHEK PERFORMA SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K070585(TRADITIONAL)
ATTN: SCOTT THIEL PHONE NO : 317-845-2000
9115 HAGUE RD. SE DECISION MADE: 25-MAY-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
RUBICOR MEDICAL, INC. 510(k) NO: K071048(SPECIAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
25 HARTFORD AVE. SE DECISION MADE: 15-MAY-07
SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE MULTI-PLATFORM SYSTEM
SCITON, INC. 510(k) NO: K070388(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
925 COMMERCIAL ST. SE DECISION MADE: 02-MAY-07
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT
SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K062784(ABBREVIATED)
ATTN: YUNHUA REN PHONE NO : 86 571 81957767
34 MCNAMARA STREET SE DECISION MADE: 04-MAY-07
STOUGHTON, MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
SENORX, INC. 510(k) NO: K071229(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800
11 COLUMBIA SE DECISION MADE: 18-MAY-07
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
SENSACARE LTD. 510(k) NO: K070086(TRADITIONAL)
ATTN: STEVEN CHANG PHONE NO : 02 879 71943
2F, NO. 13, LANE 28, SEC. 1 SE DECISION MADE: 10-MAY-07
HUANSHAN RD. 510(k) SUMMARY AVAILABLE FROM FDA
NEI HU, TAIPEI, CHINA (TAIWAN) 114THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SENTINEL CLIN CHEM CAL
SENTINEL CH. SRL 510(k) NO: K070971(TRADITIONAL)
ATTN: FABIO ROTA PHONE NO : 39 02 34551448
VIA ROBERT KOCH, 2 SE DECISION MADE: 23-MAY-07
MILANO, ITALY 20152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTR SYRINGE
SEPTODONT 510(k) NO: K063634(ABBREVIATED)
ATTN: WAYNE H MATELSKI PHONE NO : 202-857-6340
1050 CONNECTICUT AVE., NW SE DECISION MADE: 11-MAY-07
WASHINGTON, DC 20036 510(k) STATEMENT
DEVICE: SERADYN QMS TOPIRAMATE
SERADYN INC. 510(k) NO: K070645(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
7998 GEORGETOWN RD. SUITE 1000 SE DECISION MADE: 17-MAY-07
INDIANAPOLIS, IN 46268 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM
SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K070982(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925-556-1302
7263 CRONIN CIRCLE SE DECISION MADE: 02-MAY-07
DUBLIN, CA 94568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHM TOUCH Q 2-WAY
SHOCKIM ENTERPRISES, LTD. 510(k) NO: K063743(TRADITIONAL)
ATTN: NICOLAAS C BESSELING PHONE NO : 949-466-7472
28711 JAEGER DRIVE SE DECISION MADE: 24-MAY-07
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO IMAGING (VERSION V30)
SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K071114(TRADITIONAL)
ATTN: EVA REITER PHONE NO : 499 131 842680
HENKESTRASSE 127 SE DECISION MADE: 22-MAY-07
ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP
SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K071017(SPECIAL)
ATTN: DEBORAH L MORRIS PHONE NO : 310-645-8200
5210 PACIFIC CONCOURSE DR. SE DECISION MADE: 02-MAY-07
LOS ANGELES, CA 90045-6900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071015(SPECIAL)
ATTN: KIMBERLY RENDON PHONE NO : 610-448-1773
51 VALLEY STREAM PKWY. SE DECISION MADE: 10-MAY-07
J-15 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071068(SPECIAL)
ATTN: CRISTIN WETHERBEE PHONE NO : 865-218-2343
810 INNOVATION DRIVE SE DECISION MADE: 14-MAY-07
KNOXVILLE, TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071314(TRADITIONAL)
ATTN: MARTINA VOGT PHONE NO : 425-557-1434
1230 SHOREBIRD WAY SE DECISION MADE: 22-MAY-07
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071036(SPECIAL)
ATTN: MARTINA VOGT PHONE NO : 425-557-1434
1230 SHOREBIRD WAY SE DECISION MADE: 16-MAY-07
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
SLEEPNET CORPORATION 510(k) NO: K063806(TRADITIONAL)
ATTN: PAUL CHIESA PHONE NO : 603-624-1911
1050 PERIMETER RD. SE DECISION MADE: 17-MAY-07
MANCHESTER AIR CENTER 510(k) SUMMARY AVAILABLE FROM FDA
MANCHESTER, NH 03103
DEVICE: SBI DISTAL RADIUS VOLAR PLATING SYSTEM
SMALL BONE INNOVATIONS INC. 510(k) NO: K070793(TRADITIONAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 30-MAY-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW KINSA RC SUTURE ANCHOR
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K070908(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 16-MAY-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COFIELD TOTAL SHOULDER SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K070565(ABBREVIATED)
ATTN: MARLON D RIDLEY PHONE NO : 901-399-6055
1450 E BROOKS RD SE DECISION MADE: 18-MAY-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS A
SMITHS MEDICAL MD, INC. 510(k) NO: K070116(TRADITIONAL)
ATTN: PHIL NEURURER PHONE NO : 651-628-7592
1265 GREY FOX RD. SE DECISION MADE: 23-MAY-07
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
SONOSITE,INC. 510(k) NO: K071134(TRADITIONAL)
ATTN: DAINA L GRAHAM PHONE NO : 425-951-1275
21919 30TH DRIVE SE. SE DECISION MADE: 08-MAY-07
BOTHELL, WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ABSORBATACK AND APPLICATOR
SORBX, LLC 510(k) NO: K071061(TRADITIONAL)
ATTN: MARY LEE WILLETS PHONE NO : 904-610-1046
PO BOX 3614 SE DECISION MADE: 16-MAY-07
PONTE VEDRA BEACH, FL 32004 510(k) STATEMENT
DEVICE: ENDOSSEOUS DENTAL IMPLANT SYSTEM
SOUTHERN IMPLANTS, INC. 510(k) NO: K070905(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10355 B DEMOCRACY LANE SE DECISION MADE: 24-MAY-07
FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX
SOUTHERN SPINE, LLC 510(k) NO: K063764(SPECIAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 16-MAY-07
ALPHARETTA, GA 31201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
SPSMEDICAL SUPPLY CORP. 510(k) NO: K070595(TRADITIONAL)
ATTN: GARY SOCOLA PHONE NO : 585-359-0130
6789 WEST HENRIETTA RD. SE DECISION MADE: 24-MAY-07
RUSH, NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
ST. JUDE MEDICAL 510(k) NO: K063638(TRADITIONAL)
ATTN: SHANNON SPRINGER PHONE NO : 763-383-0900
6550 WEDGWOOD RD. NORTH SE DECISION MADE: 11-MAY-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
MAPLE GROVE, MN 55311
DEVICE: MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
ST. JUDE MEDICAL 510(k) NO: K070902(SPECIAL)
ATTN: KAREN J MCKELVEY PHONE NO : 651-632-9454
1350 ENERGY LN., SUITE 110 SE DECISION MADE: 01-MAY-07
ST. PAUL, MN 55108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WN SYNOCTA GOLD ABUTMENT
STRAUMANN USA 510(k) NO: K063789(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 10-MAY-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750
STRYKER CORP. 510(k) NO: K063480(TRADITIONAL)
ATTN: JEAN SHEPPARD PHONE NO : 269-323-7700
4100 E. MILHAM AVE. SE DECISION MADE: 22-MAY-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYS
STRYKER CORP. 510(k) NO: K070368(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 04-MAY-07
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER PEEK ZIP SUTURE ANCHOR
STRYKER ENDOSCOPY 510(k) NO: K070758(TRADITIONAL)
ATTN: ERICA A WALTERS PHONE NO : 408-754-2078
5900 OPTICAL CT. SE DECISION MADE: 16-MAY-07
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
SUN SCIENTIFIC LLC 510(k) NO: K070457(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 16-MAY-07
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 247 BP DEVICE
SUNTECH MEDICAL, INC. 510(k) NO: K070750(ABBREVIATED)
ATTN: CHUCK SETZER PHONE NO : 919-654-2332
507 AIRPORT BOULEVARD SE DECISION MADE: 02-MAY-07
SUITE 117 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SHARPOINT PDO (POLYDIOXANONE) SUTURES
SURGICAL SPECIALTIES CORP. 510(k) NO: K063680(TRADITIONAL)
ATTN: ELIZABETH LAZARO PHONE NO : 610-404-1000
100 DENNIS DR. SE DECISION MADE: 09-MAY-07
READING, PA 19606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST
SWISSRAY INTERNATIONAL, INC. 510(k) NO: K070678(TRADITIONAL)
ATTN: JOHN MONAHAN PHONE NO : 908-353-0971
1180 MCLESTER STREET, UNIT#2 SE DECISION MADE: 02-MAY-07
ELIZABETH, NJ 07201 510(k) STATEMENT
DEVICE: REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOC
SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K070327(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 25-MAY-07
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER INTRADISCAL RF GENERATOR
SYNERGETICS, INC. 510(k) NO: K063489(TRADITIONAL)
ATTN: DAN REGAN PHONE NO : 484-690-9000
3600 HORIZON DRIVE SE DECISION MADE: 23-MAY-07
VALLEY FORGE, PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
SYNTHES (USA) 510(k) NO: K070843(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY. SE DECISION MADE: 02-MAY-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX MODEL UF1000I
SYSMEX AMERICA, INC. 510(k) NO: K070910(TRADITIONAL)
ATTN: NINA M GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 25-MAY-07
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT LOCATION SOFTWARE-T
TACTILE TECHNOLOGIES, LTD. 510(k) NO: K070713(TRADITIONAL)
ATTN: URIEL WEINSTEIN PHONE NO : 972 894 84740
10 PLAUT ST. SE DECISION MADE: 02-MAY-07
RABIN SCIENTIFIC PARK 510(k) SUMMARY AVAILABLE FROM FDA
RECHOVOT, ISRAEL 76122
DEVICE: KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
TELEFLEX MEDICAL 510(k) NO: K070561(ABBREVIATED)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 25-MAY-07
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
BANNOCKBURN, IL 60015
DEVICE: TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
TERUMO CORP. 510(k) NO: K071075(TRADITIONAL)
ATTN: YOSHIAKI NAGURA PHONE NO :
44-1, 2-CHOME, HATAGAYA SE DECISION MADE: 25-MAY-07
SHIBUYA-KU, TOKYO, JAPAN 151-0072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINE
TERUMO EUROPE N.V. 510(k) NO: K070264(TRADITIONAL)
ATTN: M.J. AERTS PHONE NO : 003 216 381211
RESEARCHPARK ZONE 2 SE DECISION MADE: 29-MAY-07
INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN 3001, BELGIUM 3001
DEVICE: SURFLO WINGED INFUSION SET
TERUMO EUROPE N.V. 510(k) NO: K070362(TRADITIONAL)
ATTN: M J AERTS PHONE NO : 003 216 381211
INTERLEUVENLAAN 40 SE DECISION MADE: 07-MAY-07
LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURFLO WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION (SU
TERUMO EUROPE N.V. 510(k) NO: K070547(TRADITIONAL)
ATTN: M.J. AERTS PHONE NO : 32 16 381211
RESEARCHPARK ZONE 2 SE DECISION MADE: 25-MAY-07
INTERLEUVENLAAN 40 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN, BELGIUM 3001
DEVICE: LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
THE LARYNGEAL MASK CO.,LTD. 510(k) NO: K062475(TRADITIONAL)
ATTN: FOSTER BOOP PHONE NO : 858-622-5621
4660 LA JOLLA VILLAGE DRIVE SE DECISION MADE: 09-MAY-07
SAN DIEGO, CA 92122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THEKEN ATOLL CERVICO-THORACIC SYSTEM
THEKEN SPINE LLC 510(k) NO: K070638(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 30-MAY-07
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMYLASE EPS REAGENT
THERMO FISHER SCIENTIFIC 510(k) NO: K070064(TRADITIONAL)
ATTN: MELITA LAMBIRIS PHONE NO : 613 979 04100
189-199 BROWNS RD. SE DECISION MADE: 22-MAY-07
NOBLE PARK, VICTORIA, AUSTRALIA 31510(k) STATEMENT
DEVICE: THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE
THOR INTERNATIONAL 510(k) NO: K070024(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD. SE DECISION MADE: 16-MAY-07
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77047
DEVICE: ICARE TONOMETER TA01I
TIOLAT OY 510(k) NO: K063873(TRADITIONAL)
ATTN: NELSON TOBIN PHONE NO : 813-926-3447
8404 SUNSTATE STREET SE DECISION MADE: 23-MAY-07
TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOP-RANK ADHESIVE ELECTRODE
TOP-RANK HEALTH CARE EQUIPMENT CO.510(k) NO: K070612(TRADITIONAL)
ATTN: UWE DEGENHARDT PHONE NO :
DONGGUAN ST. SE DECISION MADE: 07-MAY-07
SHANGYU CITY, CHINA 312352 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
TRINITY ORTHOPEDICS, LLC 510(k) NO: K070295(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SUITE 20 SE DECISION MADE: 21-MAY-07
SAN DIEGO,, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626,
ULTRADENT PRODUCTS, INC. 510(k) NO: K071055(SPECIAL)
ATTN: ROBERT WANG PHONE NO : 800-552-5512
505 WEST 10200 SOUTH SE DECISION MADE: 03-MAY-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ AC
ULTRADENT PRODUCTS, INC. 510(k) NO: K071106(SPECIAL)
ATTN: COREY JASEPH PHONE NO : 800-552-5512
505 WEST 10200 SOUTH SE DECISION MADE: 08-MAY-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATUR
UNION DENTAL S.A./UNIDESA.ODI 510(k) NO: K070591(TRADITIONAL)
ATTN: JOSE LUIS RODRIGUEZ PHONE NO : 011 34 918737630
PASEO DE LA ESTACION, 4 SE DECISION MADE: 11-MAY-07
TIELMES, MADRID, SPAIN 28550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALINE/ CONTRAST MEDIA INFUSION CATHETER
UTAH MEDICAL PRODUCTS, INC. 510(k) NO: K063611(TRADITIONAL)
ATTN: KEVIN L CORNWELL PHONE NO : 801-566-1200
7043 SOUTH 300 WEST SE DECISION MADE: 23-MAY-07
MIDVALE, UT 84047-1048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
VALLEYLAB,A DIVISION OF TYCO HEALT510(k) NO: K070446(TRADITIONAL)
ATTN: JULIE ROSS PHONE NO : 303-581-6773
5920 LONGBOW DR. SE DECISION MADE: 02-MAY-07
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLADDERSCAN BVI 9400 ULTRASOUND
VERATHON INCORPORATED 510(k) NO: K071217(TRADITIONAL)
ATTN: RUSS GARRISON PHONE NO : 425-867-1348
21222 30TH DRIVE SE, STE. 120 SE DECISION MADE: 17-MAY-07
BOTHELL, WA 98021-7012 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO FLOWSCREEN
VIASYS HEALTHCARE GMBH 510(k) NO: K062011(SPECIAL)
ATTN: YVETTE LLOYD PHONE NO : 714-919-3247
22745 SAVI RANCH PKWY. SE DECISION MADE: 11-MAY-07
YORBA LINDA, CA 92887 510(k) STATEMENT
DEVICE: CORSCREEN
VIASYS HEALTHCARE GMBH 510(k) NO: K070614(TRADITIONAL)
ATTN: DETLEF GROTHEER PHONE NO : 011 499 314972111
LEIBNIZSTRASSE 7 SE DECISION MADE: 04-MAY-07
HOECHBERG, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
VIDACARE CORPORATION 510(k) NO: K070759(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 21-MAY-07
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
VIDAR SYSTEMS CORP. 510(k) NO: K071193(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 30-MAY-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITREA VERSION 4.0
VITAL IMAGES, INC. 510(k) NO: K071331(ABBREVIATED)
ATTN: TIMOTHY J KAPPERS PHONE NO : 952-487-9624
5850 OPUS PARKWAY, SE DECISION MADE: 25-MAY-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW
DEVICE: VITAL CONNECT 4.1
VITAL IMAGES, INC. 510(k) NO: K071362(ABBREVIATED)
ATTN: TIMOTHY J KAPPERS, MBA,RAC PHONE NO : 952-487-9624
5850 OPUS PARKWAY, SE DECISION MADE: 30-MAY-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW
DEVICE: RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK
VOLUME INTERACTIONS PTE LTD 510(k) NO: K071054(TRADITIONAL)
ATTN: MICHAEL SIM PHONE NO : 656 222 6962
1 KIM SENG PROMENADE SE DECISION MADE: 22-MAY-07
#12-01 GREAT WORLD CITY EAST 510(k) SUMMARY AVAILABLE FROM FDA
TOWER, SINGAPORE, SINGAPORE 237994
DEVICE: 45L CORE INSUFFLATOR, MODEL F114
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K063367(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-547-0628
1480 CAMBRIDGE STREET SE DECISION MADE: 23-MAY-07
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASSTRAK IMMUNOSUPPRESSANTS KIT
WATERS CORPORATION 510(k) NO: K063868(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 25-MAY-07
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS IL
WELCH ALLYN, INC. 510(k) NO: K070964(SPECIAL)
ATTN: CHRIS HORACEK PHONE NO : 315-685-4558
4341 STATE STREET ROAD SE DECISION MADE: 18-MAY-07
PO BOX 220 510(k) SUMMARY AVAILABLE FROM FDA
SKANEATELES FALLS, NY 13153-0220
DEVICE: WELMED, INC. SURGICAL GOWNS
WELMED INC. 510(k) NO: K070431(TRADITIONAL)
ATTN: GLEN FEYE PHONE NO : 619-517-1762
1340 WEST PENNSYLVANIA AVENUE SE DECISION MADE: 24-MAY-07
SAN DIEGO, CA 92103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
WIDEMED LTD 510(k) NO: K070326(TRADITIONAL)
ATTN: DORIT WINITZ PHONE NO : 972 336 123281
7 JABOTINSKY ST SE DECISION MADE: 05-MAY-07
RAMAT GAN, ISRAEL 52520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM
WORTHAM LABORATORIES INC 510(k) NO: K060968(TRADITIONAL)
ATTN: LEON WORTHAM PHONE NO : 423-296-0090
6340 BONNY OAKS DR. SE DECISION MADE: 15-MAY-07
CHATTANOOGA, TN 37416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
WRIGHT LINEAR PUMP, INC. 510(k) NO: K071040(TRADITIONAL)
ATTN: CAROL WRIGHT PHONE NO : 724-695-0800
103-B INTERNATIONAL DR. SE DECISION MADE: 22-MAY-07
OAKDALE, PA 15071-3907 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRO-DENSE BONE VOID FILLER
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K070437(SPECIAL)
ATTN: RYAN M BELANEY PHONE NO : 901-867-4778
5677 AIRLINE RD. SE DECISION MADE: 09-MAY-07
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
ZEN STRONG MEDICAL TECHNOLOGY CO.,510(k) NO: K070473(TRADITIONAL)
ATTN: CHENG ROEI-SHENG PHONE NO : 886 224 570547
6F,NO.88 NING JING ST., SE DECISION MADE: 23-MAY-07
KEELUNG,, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLORISE
ZHERMACK S.P.A. 510(k) NO: K070677(TRADITIONAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 11-MAY-07
BEND, OR 97702 510(k) STATEMENT
DEVICE: ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A1
ZIMMER DENTAL INC. 510(k) NO: K071235(SPECIAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 30-MAY-07
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTA -S DEVICE
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K070382(TRADITIONAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-576-0133
10 POMEROY RD. SE DECISION MADE: 30-MAY-07
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
ZIMMER, INC. 510(k) NO: K070906(SPECIAL)
ATTN: MASON W ROBBINS PHONE NO : 574-371-8065
P.O. BOX 708 SE DECISION MADE: 01-MAY-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 271
TOTAL WITH SUMMARIES 236
TOTAL WITH STATEMENTS 35
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