The Food & Drug Administration released the 510(k) clearances granted during September:
September 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2010
DEVICE: NESSI OTC SPACER
PHARMACARIBE 510(k) NO: K101532(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 01-SEP-10
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SIGNS MONITOR
CRITICARE SYSTEMS, INC. 510(k) NO: K101602(SPECIAL)
ATTN: ALEX KAPLAN PHONE NO : 262 798 8282
20925 CROSSROADS CIRCLE SE DECISION MADE: 01-SEP-10
WAUKESHA WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K101506(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781 993 2414
15 NETWORK DRIVE SE DECISION MADE: 01-SEP-10
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
SPINEFRONTIER, INC. 510(k) NO: K102020(TRADITIONAL)
ATTN: JOHN SULLIVAN PHONE NO : 978 232 3990
500 CUMMINGS CENTER, STE. 3500 SE DECISION MADE: 01-SEP-10
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECICONTROL CLINCHEM MULTI 1 AND 2
ROCHE DIAGNOSTICS 510(k) NO: K102016(TRADITIONAL)
ATTN: PATRICK J STIMART PHONE NO : 317 521 3954
9115 HAGUE ROAD SE DECISION MADE: 01-SEP-10
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC 510(k) NO: K101860(SPECIAL)
ATTN: DAVID M GALSSER PHONE NO : 386 462 7661
13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 01-SEP-10
ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
MEDTRONIC CRYOCATH LP 510(k) NO: K102176(SPECIAL)
ATTN: KARI LAHTI PHONE NO : 763 526 1766
16771 CHEMIN STE-MARIE SE DECISION MADE: 01-SEP-10
KIRKLAND CA H9H5H3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN ANTI-M2-3E ELISA (IGG)
EUROIMMUN US INC 510(k) NO: K092736(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973 270 0912
95 WASHINGTON ST SE DECISION MADE: 02-SEP-10
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
EUROIMMUN US INC 510(k) NO: K091969(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973 270 0912
95 WASHINGTON ST SE DECISION MADE: 02-SEP-10
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
EXACTECH, INC. 510(k) NO: K093430(TRADITIONAL)
ATTN: GRAHAM CUTHBERT PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 02-SEP-10
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
SMITH & NEPHEW, INC. 510(k) NO: K100795(TRADITIONAL)
ATTN: SHEREEN MYERS PHONE NO : 901 399 6325
1450 EAST BROOKS RD. SE DECISION MADE: 02-SEP-10
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VU APOD INTERVERTEBRAL BODY FUSION DEVICE
THEKEN SPINE LLC 510(k) NO: K101310(TRADITIONAL)
ATTN: GLENN STIEGMAN PHONE NO : 202 552 5800
1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 02-SEP-10
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPS CONTAINER
CIXI LEINUO PLASTIC CO. LTD 510(k) NO: K101567(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 541 376 5063
NO. 56 LUOMING SOUTH ROAD GUANHAIWSE DECISION MADE: 02-SEP-10
NINGBO CH 315316 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
RESPIRONICS, INC. 510(k) NO: K101130(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120
1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 02-SEP-10
MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIOX MINO MODEL 09-1000
AEROCRINE AB 510(k) NO: K101034(SPECIAL)
ATTN: JOHANNA KARLING PHONE NO : 468 629 0780
SUNDBYBERGSVAGEN 9 P.O. BOX 1024 SE DECISION MADE: 02-SEP-10
SOLNA SW SE-17121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NMI IC
NAVILYST MEDICAL, INC. 510(k) NO: K101326(ABBREVIATED)
ATTN: NICHOLAS CONDAKES PHONE NO : 508 658 7931
26 FOREST STREET SE DECISION MADE: 02-SEP-10
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY TOUCH
MHC MEDICAL PRODUCTS 510(k) NO: K102178(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 02-SEP-10
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
VERILUX 510(k) NO: K091125(TRADITIONAL)
ATTN: RYAN DOUGLAS PHONE NO : 651 203 2100
391 BRIDGE POINT DR. SE DECISION MADE: 03-SEP-10
SOUTH ST. PAUL MN 55075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRUISER 18 GUIDEWIRE
BRIVANT, LTD. 510(k) NO: K102211(SPECIAL)
ATTN: TOMAS FUREY PHONE NO : 353 91 385037
PARKMORE WEST BUSINESS PARK SE DECISION MADE: 03-SEP-10
GALWAY, COUNTY GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5
AALTO SCIENTIFIC LTD. 510(k) NO: K100718(TRADITIONAL)
ATTN: BRANDON J PEREZ PHONE NO : 760 431 7922
1959 KELLOGG AVE. SE DECISION MADE: 03-SEP-10
CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE
COVIDIEN 510(k) NO: K100418(TRADITIONAL)
ATTN: WING NG PHONE NO : 508 261 6596
15 HAMPSHIRE STREET SE DECISION MADE: 03-SEP-10
MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPAPLUS ANALYZER
THE BINDING SITE 510(k) NO: K100455(TRADITIONAL)
ATTN: JAY GELLER PHONE NO : 310 979 9966
12100 WILSHIRE BLVD SUITE 500 SE DECISION MADE: 03-SEP-10
LOS ANGELES CA 90025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
MEDTRONIC PERFUSION SYSTEMS 510(k) NO: K101186(TRADITIONAL)
ATTN: CARALEE WALTON PHONE NO : 763 514 9851
7611 NORTHLAND DR. SE DECISION MADE: 03-SEP-10
MINNEAPOLIS MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPERLOC COMPLETE
BIOMET, INC. 510(k) NO: K101086(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574 267 6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 03-SEP-10
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
EXACT MEDICAL MANUFACTURING, INC 510(k) NO: K101593(TRADITIONAL)
ATTN: ROBERT O DEAN PHONE NO : 716 440 7362
1083 DELAWARE AVE SE DECISION MADE: 03-SEP-10
BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROMIAPEX MODEL A-15
ROMIDAN LTD 510(k) NO: K101054(TRADITIONAL)
ATTN: EITAN MARGALIT PHONE NO : 972 373 60099
5 SIMCHA HOLZBERG ST. SE DECISION MADE: 03-SEP-10
KIRYAT-ONO IS 55022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOGRAPH MCT FAMILY
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K101550(TRADITIONAL)
ATTN: ALAINE MEDIO PHONE NO : 865 218 2703
810 INNOVATION DR. SE DECISION MADE: 03-SEP-10
KNOXVILLE TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSTAPLE CHILL
BIOMEDICAL ENT., INC. 510(k) NO: K102107(SPECIAL)
ATTN: JOE W SOWARD PHONE NO : 210 677 0354
14785 OMICRON DR., SUITE 205 SE DECISION MADE: 03-SEP-10
SAN ANTONIO TX 78245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECLIPSE TREATMENT PLANNING SYSTEM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K102011(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650 424 5731
3100 HANSEN WAY SE DECISION MADE: 03-SEP-10
PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE
WEAR SAFE (MALAYSIA) SDN. BHD. 510(k) NO: K101799(TRADITIONAL)
ATTN: MOHD AZLAN PHONE NO : 603 329 23088
LOT PT 13726,JALAN HAJI SALLEH OFFSE DECISION MADE: 03-SEP-10
KLANG, SELANGOR DARUL EHSAN MY510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
3M COMPANY 510(k) NO: K101834(TRADITIONAL)
ATTN: JIZHONG JIN PHONE NO : 651 733 6655
3M CENTER, BLDG. 275-05-W-06 SE DECISION MADE: 03-SEP-10
ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
SURGICAL INNOVATIONS GROUP PLC 510(k) NO: K100442(TRADITIONAL)
ATTN: MIKE WHITE PHONE NO : 440 113 2307597
CLAYTON WOOD HOUSE 6 CLAYTON WOOD SE DECISION MADE: 07-SEP-10
LEEDS WEST YORKSHIRE UK LS16,6Q510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL
HERAEUS KULZER, LLC 510(k) NO: K101617(TRADITIONAL)
ATTN: CHERYL ZIMMERMAN PHONE NO : 574 299 5444
300 HERAEUS WAY SE DECISION MADE: 07-SEP-10
SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE
PT. SMART GLOVE INDONESIA 510(k) NO: K101630(TRADITIONAL)
ATTN: CHO SOW FONG PHONE NO : 626 179 40100
JL RAYA MEDAN-LUBUK PAKAM KM19 TANSE DECISION MADE: 07-SEP-10
MORAWA,DELI SERDANG,SUMATERA U 510(k) STATEMENT
DEVICE: MERIT BIPOLAR COAGULATION PROBE
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K102273(SPECIAL)
ATTN: DAN W LINDSAY PHONE NO : 801 208 4408
1600 WEST MERIT PKWY. SE DECISION MADE: 07-SEP-10
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-ABLATIVE WRINKLE TREATMENT HANDPIECE
ELLMAN INT'L INC. 510(k) NO: K102368(SPECIAL)
ATTN: JONATHAN ACHENBACH PHONE NO : 763 257 7125
3333 ROYAL AVENUE SE DECISION MADE: 07-SEP-10
OCEANSIDE NY 11572 3625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6F ENGAGE/ENGAGE TR INTRODUCER
ST. JUDE MEDICAL 510(k) NO: K101883(SPECIAL)
ATTN: VENKATA DAMARAJU PHONE NO : 651 756 3259
14901 DEVEAU PL. SE DECISION MADE: 07-SEP-10
MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K101868(SPECIAL)
ATTN: PAUL BIGGINS PHONE NO : 714 730 5000
2441 MICHELLE DR SE DECISION MADE: 07-SEP-10
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS MINIMASTER LED
EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K093723(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE PHONE NO : 919 859 4207
49 PLAIN ST. SE DECISION MADE: 08-SEP-10
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANDHELD PULSE OXIMETER MODEL M800
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K101694(SPECIAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 08-SEP-10
SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
ROCHE DIAGNOSTICS 510(k) NO: K101456(SPECIAL)
ATTN: SUSAN HOLLANDBECK PHONE NO : 317 521 3380
9115 HAGUE ROAD SE DECISION MADE: 08-SEP-10
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
THERMAGE, INC. 510(k) NO: K101490(TRADITIONAL)
ATTN: KRISS FOSS PHONE NO : 510 780 4657
25881 INDUSTRIAL BLVD. SE DECISION MADE: 08-SEP-10
HAYWARD CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIGAGE MODEL 1243RA, 1243RB, 1243RE
3M COMPANY 510(k) NO: K101249(TRADITIONAL)
ATTN: SUZANNE LEUNG PHONE NO : 651 575 8052
3M CENTER, BLDG. 275-05-W-06 SE DECISION MADE: 08-SEP-10
ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
SGMP CO., LTD. 510(k) NO: K101646(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775 342 2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 08-SEP-10
SPARKS NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SNORE GUARD ADVANCE
RANIR LLC 510(k) NO: K102118(SPECIAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202 637 5735
555 THIRTEENTH STREET, NW SE DECISION MADE: 08-SEP-10
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
VISIONSCOPE TECHNOLOGIES, LLC 510(k) NO: K101734(TRADITIONAL)
ATTN: LIM CHEUNG PH.D PHONE NO : 978 776 9512
2352 MAIN STREET SUITE 303 SE DECISION MADE: 08-SEP-10
CONCORD MA 01742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12" STERILE PAIRS
KIMBERLY-CLARK CORP. 510(k) NO: K102032(TRADITIONAL)
ATTN: LESTER F PADILLA PHONE NO : 678 352 6766
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 08-SEP-10
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COBAS 8000 MODULAR SERIES ANALYZER
ROCHE DIAGNOSTICS CORP. 510(k) NO: K100853(SPECIAL)
ATTN: ANGELO PEREIRA PHONE NO : 317 521 3544
9115 HAGUE RD. SE DECISION MADE: 09-SEP-10
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K100985(TRADITIONAL)
ATTN: MICHAEL DAVIS PHONE NO : 205 967 7880
2300 RIVERCHASE CENTER SE DECISION MADE: 09-SEP-10
BIRMINGHAM AL 35244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
DELMA MEDICAL INSTRUMENT (GUANGZHO510(k) NO: K101551(TRADITIONAL)
ATTN: LEON LU PHONE NO : 302 857 0008
3500 SOUTH DUPONT HIGHWAY SE DECISION MADE: 09-SEP-10
DOVER DE 19901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTRONIC C315 DELIVERY CATHETER
MEDTRONIC INC. 510(k) NO: K101885(SPECIAL)
ATTN: BRUCE BACKLUND PHONE NO : 763 526 0603
8200 CORAL SEA STREET NE MS MV S11SE DECISION MADE: 09-SEP-10
MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTA VESSEL OCCLUSION SYSTEM (VOS)
NFOCUS NEUROMEDICAL, INC. 510(k) NO: K091952(ABBREVIATED)
ATTN: BOB O'HOLLA PHONE NO : 908 337 8478
2191 E. BAYSHORE ROAD SUITE 100 SE DECISION MADE: 10-SEP-10
PALO ALTO CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDEAVOUR MONITORING SYSTEM
MINDRAY DS USA, INC. 510(k) NO: K102004(ABBREVIATED)
ATTN: RUSSELL OLSEN PHONE NO : 201 995 8391
800 MACARTHUR BLVD SE DECISION MADE: 10-SEP-10
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL FACE MASK
EPARD PROTECTIVE PRODUCTS, LTD 510(k) NO: K093901(TRADITIONAL)
ATTN: DARREN REEVES PHONE NO : 804 307 7706
15637 FOX COVE CIRCLE SE DECISION MADE: 10-SEP-10
MOSELEY VA 23120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STLASE DIODE LASER
DENTAL PHOTONICS, INC 510(k) NO: K094049(TRADITIONAL)
ATTN: MARCY MOORE PHONE NO : 919 363 2432
16 APPLETON ST SE DECISION MADE: 10-SEP-10
WALTHAM MA 02453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIRSCHNER AND GUIDE WIRES
SMT SCHILLING METALLTECHNIK GMBH 510(k) NO: K100736(TRADITIONAL)
ATTN: ANDRE WEINGERL PHONE NO : 049 746 3995413
GRIESWEG 47 SE DECISION MADE: 10-SEP-10
MUEHLHEIM, BADEN-WURTTEMBERG GM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
ZIMMER, INC. 510(k) NO: K101696(TRADITIONAL)
ATTN: STEPHEN G MCKELVEY, MA, RAC PHONE NO : 574 372 4944
P.O. BOX 708 SE DECISION MADE: 10-SEP-10
WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K101425(TRADITIONAL)
ATTN: ELISABETH WARRINER PHONE NO : 916 374 3244
1584 ENTERPRISE BLVD SE DECISION MADE: 10-SEP-10
WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAXX XD SYSTEM
SPINE WAVE, INC. 510(k) NO: K101288(TRADITIONAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203 712 1839
THREE ENTERPRISE DR. SUITE 210 SE DECISION MADE: 10-SEP-10
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINA-QUANT ALBUMIN GEN 2
ROCHE DIAGNOSTICS 510(k) NO: K101203(TRADITIONAL)
ATTN: KATHIE J GOODWIN PHONE NO : 317 521 3831
9115 HAGUE RD SE DECISION MADE: 10-SEP-10
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS FERRITIN CALCHECK 5
ROCHE DIAGNOSTICS 510(k) NO: K102267(TRADITIONAL)
ATTN: SARAH BAUMANN PHONE NO : 317 521 3952
9115 HAGUE ROAD SE DECISION MADE: 10-SEP-10
INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUGARD NITILE GREY COLOR
TERANG NUSA SDN BHD 510(k) NO: K102230(SPECIAL)
ATTN: ROBERT HILL PHONE NO : 609 774 7171
1, JALAN 8, PENGKALAN CHEPA 2 IND.SE DECISION MADE: 10-SEP-10
KOTA BHARU, KELANTAN MY 16100 510(k) STATEMENT
DEVICE: STERILE SALINE SOLUTION
CACHET PHARMACEUTICALS PVT. LTD. 510(k) NO: K093367(TRADITIONAL)
ATTN: SHIVKUMAR AGRAWAL PHONE NO : 919 967 655855
415 SHAH NAHAR, WORLI SE DECISION MADE: 10-SEP-10
MUMBAI IN 400 018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
TYCO ELECTRONICS CORPORATION 510(k) NO: K102430(TRADITIONAL)
ATTN: DENNIS M GILKEY PHONE NO : 503 673 5027
10025 SW FREEMAN CT. SE DECISION MADE: 10-SEP-10
WILSONVILLE OR 97070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BLOOD PRESSURE METER, MODEL CH-658
CITIZEN SYSTEMS JAPAN CO., LTD. 510(k) NO: K102303(SPECIAL)
ATTN: NATHAN A BEAVER PHONE NO : 202 295 4039
3000 K STREET NW SUITE 600 SE DECISION MADE: 10-SEP-10
WASHINGTON DC 20007 5143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E.S.O. (ELECTRO SENSOR OXI)
L.D. TECHNOLOGY, LLC 510(k) NO: K102442(TRADITIONAL)
ATTN: ALBERT MAAREK PHONE NO : 305 379 9900
100 N. BISCAYNE BLVD SUITE 500 SE DECISION MADE: 10-SEP-10
MIAMI FL 33132 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRANSCORP ACIF SYSTEM
TRANSCORP, INC. 510(k) NO: K092794(TRADITIONAL)
ATTN: ANDREW RODENHOUSE PHONE NO : 616 706 3903
1000 100TH ST. SW, SUITE F SE DECISION MADE: 13-SEP-10
BYRON CENTER MI 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
EUROIMMUN US INC 510(k) NO: K100017(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973 270 0912
95 WASHINGTON ST SE DECISION MADE: 13-SEP-10
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARARCH
ORMCO CORP. 510(k) NO: K101676(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 13-SEP-10
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
KEYMED (MEDICAL & INDUSTRIAL EQUIP510(k) NO: K100899(TRADITIONAL)
ATTN: RON WARREN PHONE NO : 858 753 1961
11440 WEST BERNARDO DRIVE SUITE 30SE DECISION MADE: 13-SEP-10
SAN DIEGO CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RXPEAKFLOW
NOBLE MARKETING 510(k) NO: K101380(TRADITIONAL)
ATTN: LAURA LYONS PHONE NO : 317 569 9500
11460 N. MERIDIAN ST. SUITE 150 SE DECISION MADE: 13-SEP-10
CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
NEW STAR LASERS, INC. 510(k) NO: K101783(TRADITIONAL)
ATTN: NATALIE R VOLLRATH PHONE NO : 916 677 1900
9085 FOOTHILLS BLVD. SE DECISION MADE: 13-SEP-10
ROSEVILLE CA 95747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
MOLDEX/METRIC, INC. 510(k) NO: K102173(ABBREVIATED)
ATTN: MARK MEINECKE PHONE NO : 310 837 6500
10111 WEST JEFFERSON BLVD. SE DECISION MADE: 13-SEP-10
CULVER CITY CA 90232 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
AMSINO INTERNATIONAL, INC. 510(k) NO: K101824(TRADITIONAL)
ATTN: JESUS FARINAS PHONE NO : 909 626 5888
855 TOWNE CENTER DR. SE DECISION MADE: 13-SEP-10
POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW INSTRUMENT TRAYS
SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K092551(TRADITIONAL)
ATTN: CHRISTINA FLORES PHONE NO : 508 261 3705
150 MINUTEMAN RD. SE DECISION MADE: 14-SEP-10
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST AIA-PACK CYSTATIN C, MODEL 025217
TOSOH BIOSCIENCE, INC. 510(k) NO: K093960(TRADITIONAL)
ATTN: JUDITH K OGDEN PHONE NO : 650 636 8112
6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 14-SEP-10
SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK
BIO-RAD, DIAGNOSTICS GRP. 510(k) NO: K100727(TRADITIONAL)
ATTN: SUZANNE PARSONS PHONE NO : 949 598 1467
9500 JERONIMO RD. SE DECISION MADE: 14-SEP-10
IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
BREDENT GMBH & CO.KG 510(k) NO: K101064(TRADITIONAL)
ATTN: ANDREA PECSI PHONE NO : 497 462 924051
SCHWARZWALDSTRASSE 5 SE DECISION MADE: 14-SEP-10
TUTTLINGEN, BAWU GM 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CABLECAP MODEL: WLF, STZ, ACM
SENSORMED 510(k) NO: K101496(TRADITIONAL)
ATTN: WILLIAM MILAM PHONE NO : 865 216 6307
2450 EJ CHAPMAN DR., SUITE 104 SE DECISION MADE: 14-SEP-10
KNOXVILLE TN 37996 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPERED SCREW-VENT T IMPLANT
ZIMMER DENTAL INC. 510(k) NO: K101977(TRADITIONAL)
ATTN: JEREMY MARKOVICH PHONE NO : 760 929 4300
1900 ASTON AVE. SE DECISION MADE: 14-SEP-10
CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
OMNI LIFE SCIENCE, INC. 510(k) NO: K101976(SPECIAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 774 226 1852
50 O'CONNELL WAY SE DECISION MADE: 14-SEP-10
EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIWAVE3
ART OPTICAL CONTACT LENS, INC. 510(k) NO: K100221(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970 243 5490
806 KIMBALL AVENUE SE DECISION MADE: 14-SEP-10
GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMIX PANORAD AND SOMARAD
IMIX ADR FINLAND OY 510(k) NO: K101435(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 239 234 1735
8870 RAVELLO CT SE DECISION MADE: 15-SEP-10
NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEPILEX BORDER AG DRESSING
MOLNLYCKE HEALTH CARE 510(k) NO: K100029(TRADITIONAL)
ATTN: STEVEN DOWDLEY PHONE NO : 678 451 8062
5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 15-SEP-10
NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
BIOLITEC, INC. 510(k) NO: K100726(TRADITIONAL)
ATTN: HARRY HAYES PHONE NO : 413 250 0779
1349 MAIN ROAD SE DECISION MADE: 15-SEP-10
GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
ABBOTT MEDICAL OPTICS INC 510(k) NO: K093254(TRADITIONAL)
ATTN: KESLEY E GALLAGHER PHONE NO : 714 247 8930
1700 E. ST. ANDREW PLACE SE DECISION MADE: 15-SEP-10
SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRACE
IZI MEDICAL PRODUCTS INC. 510(k) NO: K101373(TRADITIONAL)
ATTN: HELEN SHAFER PHONE NO : 410 594 9403
7020 TUDSBURY RD. SE DECISION MADE: 15-SEP-10
BALTIMORE MD 21244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTVUE MODEL RTVUE 100
OPTOVUE, INC. 510(k) NO: K101505(TRADITIONAL)
ATTN: JOHN TALARICO PHONE NO : 510 623 8868
45531 NORTHPORT LOOP W. SE DECISION MADE: 15-SEP-10
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEROS TCP GRANULES
MATHYS LTD 510(k) NO: K101426(TRADITIONAL)
ATTN: LINDA SCHULZ PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 15-SEP-10
SAN DIEGO CA 92130 8587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECO SUPERGEL
CERACARTA SPA 510(k) NO: K101429(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035
P.O. BOX 560 SE DECISION MADE: 15-SEP-10
STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
SYNTHES (USA) LLC 510(k) NO: K101536(TRADITIONAL)
ATTN: LISA GRANEY PHONE NO : 610 719 1286
1301 GOSHEN PARKWAY SE DECISION MADE: 15-SEP-10
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMED X-FIX
TRIMED, INC. 510(k) NO: K101375(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661 312 7150
28337 MAITLAND LANE SE DECISION MADE: 15-SEP-10
SAUGUS CA 91350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
ST. JUDE MEDICAL 510(k) NO: K101968(SPECIAL)
ATTN: SUSAN ENGELSON PHONE NO : 408 522 6283
701 EAST EVELYN AVENUE SE DECISION MADE: 15-SEP-10
SUNNYVALE CA 94086 6527 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
COVIDIEN 510(k) NO: K102291(TRADITIONAL)
ATTN: TIM M LOHNES PHONE NO : 203 492 5462
60 MIDDLETOWN DR SE DECISION MADE: 15-SEP-10
NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL PROPAQ M
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K102174(TRADITIONAL)
ATTN: PAUL DIAS PHONE NO : 978 421 9413
269 MILL ROAD SE DECISION MADE: 15-SEP-10
CHELMSFORD MA 01824 4105 510(k) STATEMENT
DEVICE: ITOTAL CR KNEE REPLACEMENT SYSTEM
CONFORMIS, INC. 510(k) NO: K094050(TRADITIONAL)
ATTN: AMITA S SHAH PHONE NO : 781 345 9164
2 FOURTH AVENUE SE DECISION MADE: 16-SEP-10
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK
RESPIRONICS, INC. 510(k) NO: K101129(SPECIAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120
1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 16-SEP-10
MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MYRAY HYPERION
CEFLA DENTAL GROUP 510(k) NO: K101661(TRADITIONAL)
ATTN: CYNTHIA J NOLTE, PH.D. PHONE NO : 919 859 4207
49 PLAIN STREET SE DECISION MADE: 16-SEP-10
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPATCH SOFT TISSUE REPAIR MATRIX
CRYOLIFE, INC. 510(k) NO: K101587(TRADITIONAL)
ATTN: BRYAN BROSSEAU PHONE NO : 770 419 3355
1655 ROBERTS BLVD., N.W. SE DECISION MADE: 16-SEP-10
KENNESAW GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BABY QUASAR
SILVER BAY, LLC 510(k) NO: K091467(TRADITIONAL)
ATTN: DANIEL KAMM, P.E. PHONE NO : 847 374 8854
333 MILFORD ROAD SE DECISION MADE: 17-SEP-10
DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM ("V.A.C. ULTA THERAPY SYSTEM") MODEL V.A.C. ULTA THERAPY UNIT MODEL U
KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K100657(TRADITIONAL)
ATTN: MARGARET MARSH PHONE NO : 210 255 6481
6203 FARINON DRIVE SE DECISION MADE: 17-SEP-10
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
SMITH & NEPHEW, INC. 510(k) NO: K100787(TRADITIONAL)
ATTN: LAURA D REYNOLDS PHONE NO : 727 329 7702
970 LAKE CARILLON DR. SUITE 110 SE DECISION MADE: 17-SEP-10
ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVIVATOR
HERSILL, S.L. 510(k) NO: K094003(ABBREVIATED)
ATTN: ANA MARIA ROMERO PHONE NO : 349 161 64111
PUERTO DE NAVACERRADA, 3 SE DECISION MADE: 17-SEP-10
MOSTOLES ( MADRID) SP 28935 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
ACUTE INNOVATIONS LLC 510(k) NO: K101170(TRADITIONAL)
ATTN: MARIAH KNIGHT PHONE NO : 503 686 7200
21421 NW JACOBSON RD. SUITE 700 SE DECISION MADE: 17-SEP-10
HILLSBORO OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC FUJI TEMP
GC AMERICA, INC. 510(k) NO: K101420(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708 897 4042
3737 WEST 127TH ST. SE DECISION MADE: 17-SEP-10
ALSIP IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-BASIC SINGLE BREAST PUMP
MAPA GMBH 510(k) NO: K101157(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650 279 0668
2081 LONGDEN CIRCLE SE DECISION MADE: 17-SEP-10
LOS ALTOS CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRASEAL ID
ULTRADENT PRODUCTS, INC. 510(k) NO: K101245(SPECIAL)
ATTN: DIANE ROGERS PHONE NO : 801 553 4491
505 WEST 10200 SOUTH SE DECISION MADE: 17-SEP-10
SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V)
CHROMOGENEX TECHNOLOGIES LTD 510(k) NO: K101366(TRADITIONAL)
ATTN: PETER R BEVAN PHONE NO : 155 475 5444
UNITS 1&2 HEOL RHOSYN, PARC DAFEN SE DECISION MADE: 17-SEP-10
LLANELLI, CARMARTHENSHIRE UK SA510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CO2 LASER SYSTEM
ADVANCED TECHNOLOGY LASER CO., LTD510(k) NO: K101555(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
LN 999, ZHONGSHAN #2 RD (S) SUITE SE DECISION MADE: 17-SEP-10
SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SHAPE TO FIT COMPRESSION WEAR
TSUNG HAU TECHNOLOGY CO., LTD. 510(k) NO: K101906(TRADITIONAL)
ATTN: PEGGY KUO PHONE NO :
3F, BUILDING A, NO.248-21, SINSHENSE DECISION MADE: 17-SEP-10
TAIWAN, R.O.C. TW 806 KH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513
ANDON HEALTH CO.,LTD 510(k) NO: K102353(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161
NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 17-SEP-10
TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYO-TOUCH II
MYOSCIENCE INC 510(k) NO: K102021(SPECIAL)
ATTN: TRACEY HENRY PHONE NO : 650 474 2600
525 CHESAPEAKE DRIVE SE DECISION MADE: 17-SEP-10
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-LIGHT LINE
ESPANSIONE MARKETING S.P.A 510(k) NO: K092734(TRADITIONAL)
ATTN: GUIDO BONAPACE PHONE NO : 39 335 5378686
VIA BORGO SANTA CRISTINA, 12 SE DECISION MADE: 20-SEP-10
IMOLA, BOLOGNA IT 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-
SEPPIM S.A.S. 510(k) NO: K093883(TRADITIONAL)
ATTN: DEBRA K HUTSON PHONE NO : 425 482 5174
21720 23RD DR SE SUITE 150 SE DECISION MADE: 20-SEP-10
BOTHELL WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GERATHERM UNIQUERESC
GERATHERM MEDICAL AG 510(k) NO: K093694(TRADITIONAL)
ATTN: ANDREA PECSI PHONE NO : 004 974 62924051
SCHWARZWALDSTRASSE 5 SE DECISION MADE: 20-SEP-10
TUTTLIGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMM EQUIPMENT COVER-POLYTHYLENE
EXACT MEDICAL MANUFACTURING, INC 510(k) NO: K101689(TRADITIONAL)
ATTN: ROBERT O DEAN PHONE NO : 716 440 7362
1083 DELAWARE AVE SE DECISION MADE: 20-SEP-10
BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHIMADZU COLLIMATOR R-300
SHIMADZU CORP. 510(k) NO: K101039(ABBREVIATED)
ATTN: DON KARLE PHONE NO : 310 217 8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 20-SEP-10
TORRANCE CA 90502 1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N
WMI ENTERPRISES LLC 510(k) NO: K100969(TRADITIONAL)
ATTN: MIKE WILFORD PHONE NO : 888 253 2555
1017 W. WASHINGTON, 2J SE DECISION MADE: 20-SEP-10
CHICAGO IL 60607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
CINCINNATI SUB-ZERO PRODUCTS, INC.510(k) NO: K101589(TRADITIONAL)
ATTN: STEVEN J BERKE PHONE NO : 513 772 8810
12011 MOSTELLER RD. SE DECISION MADE: 20-SEP-10
CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL SB100II FINGER PULSE OXIMETER
ATLANTEAN 510(k) NO: K101568(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 20-SEP-10
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELINE-IT MODEL RELINE-IT
MAJESTIC DRUG CO., INC. 510(k) NO: K101771(TRADITIONAL)
ATTN: ROGER S MASTRONY PHONE NO : 203 640 5047
848-1/2 DERBY AVENUE SE DECISION MADE: 20-SEP-10
ORANGE CT 06477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K102017(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650 694 5988
1230 SHOREBIRD WAY SE DECISION MADE: 20-SEP-10
MOUNTAIN VIEW CA 94039 7393 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004
EXACT MEDICAL MANUFACTURING, INC 510(k) NO: K101688(TRADITIONAL)
ATTN: ROBERT O DEAN PHONE NO : 716 440 7362
1083 DELAWARE AVE SE DECISION MADE: 20-SEP-10
BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALBOSURE POLYESTER VASCULAR PATCH
LEMAITRE VASCULAR, INC. 510(k) NO: K101740(TRADITIONAL)
ATTN: VIC ZHANG PHONE NO : 781 221 2266
63 2ND AVENUE SE DECISION MADE: 20-SEP-10
BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534
ANDON HEALTH CO.,LTD 510(k) NO: K102356(SPECIAL)
ATTN: LIU YI PHONE NO : 862 260 526161
NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 20-SEP-10
TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
ARTHROCARE CORP. 510(k) NO: K100479(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224
680 VAQUEROS AVE. SE DECISION MADE: 21-SEP-10
SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
ZIMMER SPINE, INC 510(k) NO: K100845(TRADITIONAL)
ATTN: DAVID PADGETT, RAC (US) PHONE NO : 512 918 2700
5301 RIATA PARK COURT BUILDING F SE DECISION MADE: 21-SEP-10
AUSTIN TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEGANT WHITE NITRILE EXAMINATION GLOVES POWDER FREE MODEL 1, ELEGANT BLUE NITRILE EXAMINATION GLOVES POWDER FREE MODEL,
PROFIT POINT MANUFACTURING SDN BHD510(k) NO: K101760(TRADITIONAL)
ATTN: ROBERT HILL PHONE NO : 607 787 9786
JALAN MERSING KAWASAN PERIDUSTRIA SE DECISION MADE: 21-SEP-10
KLUANG, JOHOR MY 86000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRITICAL CARE ASSESSMENT
CRITICAL PATIENT CARE, INC. 510(k) NO: K101983(TRADITIONAL)
ATTN: MARIE COSGROVE PHONE NO : 214 810 9062
4005 BLACKHAWK STREET SE DECISION MADE: 21-SEP-10
ENDINBURG TX 78539 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
STERIS CORPORATION 510(k) NO: K102462(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440 392 7695
5960 HEISLEY RD. SE DECISION MADE: 21-SEP-10
MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALGAESEAL MODEL: CAS
BZ MEDICAL INC 510(k) NO: K101097(TRADITIONAL)
ATTN: BYRON ZAHLER PHONE NO : 503 244 7348
6611 SW BURLINGAME AVE SE DECISION MADE: 22-SEP-10
PORTLAND OR 97239 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
ASAHI INTECC CO., LTD. 510(k) NO: K100578(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949 756 8252
2500 RED HILL SUITE 210 SE DECISION MADE: 22-SEP-10
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UROSTATION 3D PROSTATE SUITE
KOELIS 510(k) NO: K100793(TRADITIONAL)
ATTN: CECILE DESMULIE PHONE NO : 337 764 637588
5 AVENUE DU GRAND SABLON SE DECISION MADE: 22-SEP-10
LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSITE VERISMO SEGMENTATION TOOL V.2.0
ST. JUDE MEDICAL 510(k) NO: K101697(TRADITIONAL)
ATTN: KRIS MILLER PHONE NO : 651 523 6985
177 EAST COUNTY ROAD B SE DECISION MADE: 22-SEP-10
ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASCENT F-COAT MODEL: 006-00097
CAO GROUP, INC. 510(k) NO: K100540(TRADITIONAL)
ATTN: ROBERT LARSEN PHONE NO : 801 256 9282
4628 WEST SKYHAWK DRIVE SE DECISION MADE: 23-SEP-10
WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
ADVANCED VERTEBRAL SOLUTIONS, LLC 510(k) NO: K100037(TRADITIONAL)
ATTN: MIKE DUGERY PHONE NO : 215 534 2481
124 S. MAPLE STREET SE DECISION MADE: 23-SEP-10
AMBLER PA 19002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUSCULPT II LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K101573(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245
5 TIMBER LANE SE DECISION MADE: 23-SEP-10
NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIRM DO DIODE LASER
CYNOSURE, INC. 510(k) NO: K101601(TRADITIONAL)
ATTN: ANTHONY BURNS PHONE NO : 978 256 4200
5 CARLISLE ROAD SE DECISION MADE: 23-SEP-10
WESTFORD MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUIDE CATHETERS AND ACCESSORIES
THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K101015(TRADITIONAL)
ATTN: TIM STOUDT PHONE NO : 610 651 5000
65 GREAT VALLEY PKWY. SE DECISION MADE: 23-SEP-10
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOWIRE PTA/PTCA GUIDEWIRE
NEO METRICS, INC. 510(k) NO: K101729(TRADITIONAL)
ATTN: GENE CHAMPEAU PHONE NO : 763 559 4440
2605 FERNBROOK LANE NORTH SUITE J SE DECISION MADE: 23-SEP-10
PLYMOUTH MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
SYNTHES USA PRODUCTS LLC 510(k) NO: K102018(TRADITIONAL)
ATTN: JEFFREY L DOW PHONE NO : 484 356 9720
1230 WILSON DRIVE SE DECISION MADE: 23-SEP-10
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA SURGICAL DEVICE
MEDTECH SAS 510(k) NO: K101791(TRADITIONAL)
ATTN: BERTIN NAHUM PHONE NO : 334 671 07740
1006 RUE DE LA CROIX VERTE PARC EUSE DECISION MADE: 23-SEP-10
MONTPELLIER FR 34090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURALMAS
INNOVATIVE SURGICAL SOLUTIONS, LLC510(k) NO: K100992(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456
55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 24-SEP-10
GREAT NECK NY 10021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STALIF MIDLINE
CENTINEL SPINE 510(k) NO: K101301(SPECIAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 24-SEP-10
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOCORRO SMI TUNNEL RELEASE DEVICE
SOCORRO MEDICAL, INC. 510(k) NO: K102219(TRADITIONAL)
ATTN: ED DIAO PHONE NO : 415 362 8880
450 SUTTE STREET SUITE 500 SE DECISION MADE: 24-SEP-10
SAN FRANCISCO CA 94108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK REVISION KNEE SYSTEM
MEDACTA INTERNATIONAL, SA 510(k) NO: K102437(SPECIAL)
ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350
13721 VIA TRES VISTA SE DECISION MADE: 24-SEP-10
SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISOLED AC-POWERED LED HEADLIGHT SYSTEM
ISOLUX LLC 510(k) NO: K102266(TRADITIONAL)
ATTN: NIKOLAUS ANDREOULAKIS PHONE NO : 239 514 7454
1045 COLLIER CENTER WAY SUITE #6 SE DECISION MADE: 24-SEP-10
NAPLES FL 34110 8444 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PATIENT MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K102040(SPECIAL)
ATTN: ANA HONG PHONE NO : 86 216 4264467
5D, NO. 19, LANE 999 ZHONGSHAN RD SE DECISION MADE: 24-SEP-10
SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKVUE RSV 10
QUIDEL CORP. 510(k) NO: K101918(TRADITIONAL)
ATTN: JENNIFER S HANKARD PHONE NO : 858 552 7910
10165 MCKELLAR CT. SE DECISION MADE: 24-SEP-10
SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDI GLUCOSE CONTROL SOLUTIONS
FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K102260(TRADITIONAL)
ATTN: KENT PRUETT PHONE NO : 830 372 1391
940 CROSSROADS BLVD. SE DECISION MADE: 24-SEP-10
SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITOMATRIX
ORTHOVITA, INC. 510(k) NO: K091618(TRADITIONAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610 407 5210
45 GREAT VALLEY PKWY. SE DECISION MADE: 27-SEP-10
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K093047(TRADITIONAL)
ATTN: SHEREEN MYERS PHONE NO : 901 399 6325
1450 EAST BROOKS RD. SE DECISION MADE: 27-SEP-10
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERCU-PRO GUIDEWIRE
CARDIOSOLUTIONS INC 510(k) NO: K094062(TRADITIONAL)
ATTN: MICHELE LUCEY PHONE NO : 781 344 0801
75 MILL STREET SE DECISION MADE: 27-SEP-10
STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATEK SURGICAL GOWNS
HANGZHOU ATEK MEDICAL & TEXTILE CO510(k) NO: K100971(TRADITIONAL)
ATTN: GLEN FEYE PHONE NO : 619 517 1762
1340 WEST PENNSYLVANIA AVENUE SE DECISION MADE: 27-SEP-10
SAN DIEGO CA 92103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIRECT CROWN NATURAL 1
CANDULOR USA, INC. 510(k) NO: K101814(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010
7462 N. FIGUEROA STREET SUITE 104 SE DECISION MADE: 27-SEP-10
LOS ANGELES CA 90041 510(k) STATEMENT
DEVICE: CONSTRUX MINI PEEK SPACER SYSTEM
ORTHOFIX INC. 510(k) NO: K101812(TRADITIONAL)
ATTN: RUSSELL JOHNSON PHONE NO : 972 529 3177
1720 BRAY CENTRAL DR. SE DECISION MADE: 27-SEP-10
MCKINNEY TX 75069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VESSEL GUARDIAN
LEXION MEDICAL, LLC. 510(k) NO: K102136(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 635 0000
5000 TOWNSHIP PKWY SE DECISION MADE: 27-SEP-10
ST. PAUL MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
TANGSHAN YONKSHUN GLOVE, CO., LTD 510(k) NO: K100421(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROM 1606 BLDG 1 JIANXIANG YUAN NO.SE DECISION MADE: 27-SEP-10
ZHO, BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
HONG DI PLASTIC PRODUCTS CO, LTD. 510(k) NO: K102098(TRADITIONAL)
ATTN: JIE LIU PHONE NO : 909 590 1611
3973 SCHAEFER AVE. SE DECISION MADE: 27-SEP-10
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K091445(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 27-SEP-10
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI MAXLOCK EXTREME PLATING SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K101962(TRADITIONAL)
ATTN: DEREK LEWIS PHONE NO : 330 869 9562
1065 MEDINA ROAD SUITE 500 SE DECISION MADE: 27-SEP-10
MEDINA OH 44256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
ENCORE MEDICAL, L.P. 510(k) NO: K091956(TRADITIONAL)
ATTN: ELIZABETH ONDERLINDE PHONE NO : 512 834 6302
9800 METRIC BLVD. SE DECISION MADE: 28-SEP-10
AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
KAMIYA BIOMEDICAL CO. 510(k) NO: K093137(TRADITIONAL)
ATTN: SHAWN KAPLAN PHONE NO : 206 575 8068
12779 GATEWAY DR. SE DECISION MADE: 28-SEP-10
SEATTLE WA 98168 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
SONOMA ORTHOPEDIC PRODUCTS, INC. 510(k) NO: K100112(TRADITIONAL)
ATTN: CARLOS GONZALEZ PHONE NO : 707 526 1335
650 LARKFIELD CENTER SUITE C SE DECISION MADE: 28-SEP-10
SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
POLYMEDCO, INC. 510(k) NO: K100550(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206 262 7363
510 FURNACE DOCK RD. SE DECISION MADE: 28-SEP-10
CORTLANDT MANOR NY 10567 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUXATEMP ULTRA /STAR
DMG USA, INC. 510(k) NO: K101710(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552
5 WHITCOMB AVE. SE DECISION MADE: 28-SEP-10
AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
GLAXOSMITHKLINE CONSUMER HEALTHCAR510(k) NO: K101477(TRADITIONAL)
ATTN: WENDY MCMANUS PHONE NO : 973 889 4415
1500 LITTLETON ROAD SE DECISION MADE: 28-SEP-10
PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 YEAST CASPOFUNGIN
BIOMERIEUX, INC. 510(k) NO: K101566(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314 731 8695
595 ANGLUM RD. SE DECISION MADE: 28-SEP-10
HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX KNEE MODULAR TIBIA SYSTEM
OMNLIFE SCIENCE 510(k) NO: K101994(TRADITIONAL)
ATTN: RADHIKA TAUNTON PHONE NO : 774 226 1852
50 O'CONNELL WAY SE DECISION MADE: 28-SEP-10
EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
ALMA LASERS, INC. 510(k) NO: K102716(SPECIAL)
ATTN: TATIANA EPSTEIN PHONE NO : 224 377 2011
485 HALF DAY RD. SUITE #100 SE DECISION MADE: 28-SEP-10
BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOCTOR SURGERY DIODE LASERS FAMILY
LAMBDA S.P.A. 510(k) NO: K102036(ABBREVIATED)
ATTN: BOSCHI ALESSANDRO PHONE NO : 390 444 349165
VIA DEL'IMPRESA 1 SE DECISION MADE: 28-SEP-10
BRENDOLA, VICENZA IT 36040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAT CONCENTRATION SYSTEM
BIOMET, INC. 510(k) NO: K100114(TRADITIONAL)
ATTN: LONNIE WITHAM PHONE NO : 574 371 3095
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 29-SEP-10
WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
HEMA METRICS, LLC 510(k) NO: K093834(TRADITIONAL)
ATTN: TERRY LANIER PHONE NO : 801 389 1947
136 W. 2ND ST. SE DECISION MADE: 29-SEP-10
OGDEN UT 84404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBERLE SHAVER SYSTEM ACCESSORIES
EFS EBERLE FEINWERKTECHNISCHE SYST510(k) NO: K092977(TRADITIONAL)
ATTN: GERALD GOIGITZER PHONE NO : 954 217 8780
731-733 SHOTGUN ROAD SE DECISION MADE: 29-SEP-10
FT. LAUDERDALE FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY UNIVERSAL GRIPTION TF CONES
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K100391(TRADITIONAL)
ATTN: DAWN SINCLAIR, MA PHONE NO : 574 372 5023
700 ORTHOPAEDIC DR. SE DECISION MADE: 29-SEP-10
WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C2000 POWERED WHEELCHAIR
OTTO BOCK HEALTH CARE, LP 510(k) NO: K101524(TRADITIONAL)
ATTN: WILLIAM KABITZ PHONE NO : 763 253 5610
TWO CARLSON PARKWAY NORTH SUITE 10SE DECISION MADE: 29-SEP-10
MINNEAPOLIS MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELAY POWER WHEELCHAIR
DALTON INSTRUMENT CORP. 510(k) NO: K101611(TRADITIONAL)
ATTN: JENNIFER YU PHONE NO : 469 522 1200
3788 ARAPAHO RD SE DECISION MADE: 29-SEP-10
ADDIISON TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
LDR SPINE USA 510(k) NO: K102265(SPECIAL)
ATTN: BECKINAM NOWATZKE PHONE NO : 512 344 3407
4030 WEST BRAKER LANE SUITE 360 SE DECISION MADE: 29-SEP-10
AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
SILMET LTD. 510(k) NO: K101869(TRADITIONAL)
ATTN: SHARON CHAPLIK PHONE NO : 972 353 31474
12 HASADNA SE DECISION MADE: 29-SEP-10
OR YEHUDA IS 60200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
AMSINO INTERNATIONAL, INC. 510(k) NO: K101958(SPECIAL)
ATTN: JESUS FARINAS PHONE NO : 909 626 5888
855 TOWNE CENTER DR. SE DECISION MADE: 29-SEP-10
POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOBALLOON ABLATION SYSTEM
C2 THERAPEUTICS 510(k) NO: K101825(TRADITIONAL)
ATTN: PETER GARCIA-MEZA PHONE NO : 650 521 5304
303 CONVENTION WAY SUITE 1 SE DECISION MADE: 29-SEP-10
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EP NAVIGATOR R3
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K101311(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425 487 7312
22100 BOTHELL EVERETT HWY. P.O. BOSE DECISION MADE: 30-SEP-10
BOTHELL WA 98041 3003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
GIVEN IMAGING LTD. 510(k) NO: K101200(TRADITIONAL)
ATTN: TIM THOMAS PHONE NO : 972 490 97936
SHAAR YOKNEAM (HERMON BUILDING NEWSE DECISION MADE: 30-SEP-10
YOKNEAM (P.O.BOX 258) IS 2510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
SONOSCAPE COMPANY LIMITED 510(k) NO: K101337(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
5D, #19 LANE 999, ZHONGSHAN ROAD 9SE DECISION MADE: 30-SEP-10
SHANGHAI CH 20030 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TSRH(R) SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K101772(TRADITIONAL)
ATTN: LILA JOE PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 30-SEP-10
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
SPINE SMITH PARTNERS L.P. 510(k) NO: K102090(SPECIAL)
ATTN: LAURA LEBOEUF PHONE NO : 512 637 2068
93 RED RIVER SE DECISION MADE: 30-SEP-10
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
PHILIPS MEDICAL SYSTEMS 510(k) NO: K102495(SPECIAL)
ATTN: THERESA POOLE PHONE NO : 978 659 7621
3000 MINUTEMEN RD. SE DECISION MADE: 30-SEP-10
ANDOVER MA 01810 1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K102156(SPECIAL)
ATTN: DEREK LEWIS PHONE NO : 330 869 9562
1065 MEDINA ROAD SUITE 500 SE DECISION MADE: 30-SEP-10
MEDINA OH 44256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P200MAAF
OPTOS PLC 510(k) NO: K102492(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202 637 5815
555 THIRTEENTH ST. N.W. COLUMBIA SSE DECISION MADE: 30-SEP-10
WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
CALYPSO MEDICAL TECHNOLOGIES INC 510(k) NO: K102373(SPECIAL)
ATTN: ED VERTATSCHITSCH PHONE NO : 206 774 4205
2101 FOURTH AVE SUITE 500 SE DECISION MADE: 30-SEP-10
SEATTLE WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMALOK FACET FIXATION SYSTEM
OSTEOMED L.P. 510(k) NO: K102438(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457
8202 SHERMAN ROAD SE DECISION MADE: 30-SEP-10
CHESTERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL PROPAQ MD
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K102468(SPECIAL)
ATTN: PAUL DIAS PHONE NO : 978 421 9413
269 MILL ROAD SE DECISION MADE: 30-SEP-10
CHELMSFORD MA 01824 4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 192
TOTAL WITH SUMMARIES 188
TOTAL WITH STATEMENTS 4
