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Medical Devices
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June 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-JUN-2007 THROUGH 30-JUN-2007
DEVICE: A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
A-M SYSTEMS, INC. 510(k) NO: K063526(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 29-JUN-07
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GFX NERVE ABLATION SYSTEM
ACI, INC. 510(k) NO: K063753(TRADITIONAL)
ATTN: CLAY ANSELMO PHONE NO : 303-832-8200
555 ZANG STREET SE DECISION MADE: 20-JUN-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
DENVER, CO 80228 THIRD PARTY REVIEW
DEVICE: CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
ADVANCED CIRCULATORY SYSTEMS, INC.510(k) NO: K070490(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. #102 SE DECISION MADE: 20-JUN-07
BONITA SPRINGS, FL 34134-2015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZPACS, VERSION 3.0
ADVANCED IMAGING SOLUTIONS, LLC 510(k) NO: K062878(ABBREVIATED)
ATTN: RAY HASHEMI PHONE NO : 661-949-2131
43737 N. 15TH ST. WEST SE DECISION MADE: 27-JUN-07
LANCASTER, CA 93534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS TIBIAL NAIL
ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K070444(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 310-533-9966
2444 205TH STREET, UNIT 5 SE DECISION MADE: 14-JUN-07
TORRANCE, CA 90501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLUMBUS TOTAL KNEE SYSTEM AS
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K071220(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 01-JUN-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008,
AGA MEDICAL CORP. 510(k) NO: K071125(SPECIAL)
ATTN: JODI L RAUS PHONE NO : 763-531-3065
5050 NATHAN LANE NORTH SE DECISION MADE: 18-JUN-07
PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMAPRINT
AGENDIA BV 510(k) NO: K070675(TRADITIONAL)
ATTN: GUIDO BRINK PHONE NO : 31 20 5129161
LOUWESWEG 6 SE DECISION MADE: 22-JUN-07
AMSTERDAM, NETHERLANDS 1066 EC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
AGFA HEALTHCARE CORP. 510(k) NO: K071297(TRADITIONAL)
ATTN: TOM HOLBROOK PHONE NO : 519-746-6210
10 SOUTH ACADEMY ST. SE DECISION MADE: 22-JUN-07
GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
ALFA SCIENTIFIC DESIGNS, INC. 510(k) NO: K070660(TRADITIONAL)
ATTN: MAJID PAJOUH PHONE NO : 858-513-3888
13200 GREGG ST. SE DECISION MADE: 21-JUN-07
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLEZ SPINE CROSS CONNECTORS
ALLEZ SPINE, LLC 510(k) NO: K070460(TRADITIONAL)
ATTN: HARTMUT LOCH PHONE NO : 949-752-7885
2301 DUPONT DRIVE, SUITE 510 SE DECISION MADE: 11-JUN-07
IRVINE, CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXGUARD
ALLMED SYSTEMS INC. 510(k) NO: K070924(TRADITIONAL)
ATTN: PETER ALLEN PHONE NO : 925-468-0433
9232 KLEMETSON DRIVE SE DECISION MADE: 21-JUN-07
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALTIVA CLASSIC ACP SYSTEM
ALTIVA CORP. 510(k) NO: K070891(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704-409-1754
9800-I SOUTHERN PINE BLVD. SE DECISION MADE: 11-JUN-07
CHARLOTTE, NC 28273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERAD OMNI, MODELS AN6255 AND AN6265
ANALOGIC CORP. 510(k) NO: K071430(SPECIAL)
ATTN: DONALD J SHERRATT PHONE NO : 978-326-4000
8 CENTENNIAL DR. SE DECISION MADE: 21-JUN-07
CENTENNIAL INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
PEABODY, MA 01960
DEVICE: ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
ANGIODYNAMICS, INC. 510(k) NO: K070613(TRADITIONAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215
603 QUEENSBURY AVE. SE DECISION MADE: 29-JUN-07
QUEENSBURY, NY 12804 510(k) STATEMENT
DEVICE: SKATER BILIARY CATHETER
ANGIOTECH 510(k) NO: K070610(TRADITIONAL)
ATTN: TRUDY ESTRIDGE PHONE NO : 703-796-8927
13921 PARK CENTER ROAD SE DECISION MADE: 21-JUN-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
HERNDON, VA 20171
DEVICE: KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
ANI-KAL II, LLC 510(k) NO: K071195(TRADITIONAL)
ATTN: GERBAIL T KRISHNAMURTHY, MD PHONE NO : 503-245-9029
7570 SW WEST GATE WAY SE DECISION MADE: 20-JUN-07
PORTLAND, OR 97225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG
APPLIED DNA TECHNOLOGIES, INC. 510(k) NO: K070921(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 714-624-2347
26251 VERONA PLACE SE DECISION MADE: 29-JUN-07
MISSION VIEJO, CA 92692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS,
APPLIED DNA TECHNOLOGIES, INC. 510(k) NO: K071030(TRADITIONAL)
ATTN: FENG-YU LEE PHONE NO : 714-624-2347
6310 NANCY RIDGE DRIVE SE DECISION MADE: 29-JUN-07
SUITE 106 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: SILHOUETTE, MODEL 1000.01
ARANZ MEDICAL LIMITED 510(k) NO: K070426(TRADITIONAL)
ATTN: SHANE GOODWIN PHONE NO : 643 374 6120
GROUND FLOOR ST ELMO COURTS SE DECISION MADE: 29-JUN-07
47 HEREFORD ST. PO BOX 3894 510(k) SUMMARY AVAILABLE FROM FDA
CHRISTCHURCH, CANTERBURY, NEW ZEALAND 8013
DEVICE: ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, B
ARTHREX, INC. 510(k) NO: K071177(SPECIAL)
ATTN: MARIELA CABARCAS PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 29-JUN-07
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTELON CMC SPACER ARTHRO
ARTIMPLANT AB 510(k) NO: K061954(SPECIAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 01-JUN-07
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTELON STT SPACER
ARTIMPLANT AB 510(k) NO: K061956(TRADITIONAL)
ATTN: RUSSELL PAGANO PHONE NO : 202-546-1262
719 A STREET NE SE DECISION MADE: 07-JUN-07
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRIDE MICROCATHETER
ASAHI INTECC CO., LTD. 510(k) NO: K062885(TRADITIONAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252
1301 DOVE STREET, SUITE #350 SE DECISION MADE: 13-JUN-07
NEWPORT BEACH, CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K071064(TRADITIONAL)
ATTN: GLEN NEALLY PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 22-JUN-07
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15F
ASH ACCESS TECHNOLOGY, INC. 510(k) NO: K070572(TRADITIONAL)
ATTN: ROLAND WINGER PHONE NO : 765-742-4813
3601 SAGAMORE PKWY N SUITE B SE DECISION MADE: 26-JUN-07
LAFAYETTE, IN 47904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIS EEG MONITOR VIEW
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K062613(SPECIAL)
ATTN: VIKRAM VERMA PHONE NO : 617-559-7134
ONE UPLAND ROAD SE DECISION MADE: 18-JUN-07
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT FOR ASTRA IMPLANT
ATLANTIS COMPONENTS, INC. 510(k) NO: K070833(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 22-JUN-07
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS SPINE VERTEBRAL BODY REPLACEMENT
ATLAS SPINE INC. 510(k) NO: K071497(SPECIAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-741-1108
1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 29-JUN-07
JUPITER, FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
B. BRAUN MEDICAL, INC. 510(k) NO: K063282(TRADITIONAL)
ATTN: REBECCA STOLARICK PHONE NO : 610-596-2536
901 MARCON BLVD. SE DECISION MADE: 20-JUN-07
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K070533(TRADITIONAL)
ATTN: ;EYRE Z HERNANDO PHONE NO : 349 452 97030
LEONARDO DA VINCI, 14 B SE DECISION MADE: 21-JUN-07
MINANO MENOR, ALAVA, SPAIN 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO360' COAGULATION CATHETER
BARRX MEDICAL, INCORPORATED 510(k) NO: K071543(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 29-JUN-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, M
BD BIOSCIENCES 510(k) NO: K071141(SPECIAL)
ATTN: NOBUKO NAKAJIMA PHONE NO : 408-954-4109
2350 QUME DR. SE DECISION MADE: 06-JUN-07
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD TRITEST CD3/CD4/CD45, MODEL 340383
BD BIOSCIENCES 510(k) NO: K071143(SPECIAL)
ATTN: NOBUKO NAKAJIMA PHONE NO : 408-954-4109
2350 QUME DR. SE DECISION MADE: 06-JUN-07
SAN JOSE, CA 95131-1807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTI
BECKMAN COULTER, INC. 510(k) NO: K071002(TRADITIONAL)
ATTN: TARA VIVIANI PHONE NO : 714-961-3626
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 21-JUN-07
M/S W-110 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
BECKMAN COULTER, INC. 510(k) NO: K071277(SPECIAL)
ATTN: TARA M VIVIANI PHONE NO : 714-961-3626
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 01-JUN-07
M/S W-110 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
BECKMAN COULTER, INC. 510(k) NO: K071280(SPECIAL)
ATTN: TARA M VIVIANI PHONE NO : 714-961-3626
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 01-JUN-07
M/S W-110 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: SYNCHRON SYSTEMS CREATININE REAGENT
BECKMAN COULTER, INC. 510(k) NO: K071283(SPECIAL)
ATTN: TARA M VIVIANI PHONE NO : 714-961-3626
200 SOUTH KRAEMER BLVD. SE DECISION MADE: 01-JUN-07
M/S W-110 510(k) SUMMARY AVAILABLE FROM FDA
BREA, CA 92822-8000
DEVICE: HYPERTHERMIA PUMP
BELMONT INSTRUMENT CORP. 510(k) NO: K070654(TRADITIONAL)
ATTN: URAIWAN P LABADINI PHONE NO : 978-663-0212
780 BOSTON RD. SE DECISION MADE: 08-JUN-07
BILLERICA, MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TUR
BIO-RAD LABORATORIES INC., CLINICA510(k) NO: K070819(TRADITIONAL)
ATTN: JACKIE H BUCKLEY PHONE NO : 510-741-5309
4000 ALFRED NOBEL DR. SE DECISION MADE: 25-JUN-07
HERCULES, CA 94547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEV
BIO-RAD, DIAGNOSTICS GRP. 510(k) NO: K071319(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367
9500 JERONIMO RD. SE DECISION MADE: 26-JUN-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (L
BIOKIT S.A. 510(k) NO: K063232(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 34 938 6090
CAN MALE LLISSA D'AMUNT SE DECISION MADE: 19-JUN-07
BARCELONA, SPAIN 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
BIOKIT S.A. 510(k) NO: K070810(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 34 938 6090
CAN MALE S/N SE DECISION MADE: 08-JUN-07
LLISSA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA
BARCELONA, SPAIN 08186
DEVICE: MESOSFOL SURGICAL FILM
BIOMET MANUFACTURING CORP. 510(k) NO: K062558(TRADITIONAL)
ATTN: ERIKA MARTIN PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 20-JUN-07
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
BIOMET OSTEOBIOLOGICS 510(k) NO: K070864(TRADITIONAL)
ATTN: PALANISWAMY VIJAY PHONE NO : 574-371-1136
SE DECISION MADE: 01-JUN-07
510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL STATURE SPACERS
BIOMET SPINE 510(k) NO: K063393(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 25-JUN-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
BIOMET, INC. 510(k) NO: K071053(SPECIAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 29-JUN-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYST
BIOPLATE, INC. 510(k) NO: K070901(SPECIAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100
3643 LENAWEE AVE. SE DECISION MADE: 15-JUN-07
LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON
BOSTON SCIENTIFIC 510(k) NO: K070951(TRADITIONAL)
ATTN: BRIAN PARK PHONE NO : 858-503-1822
3574 RUFFIN RD. SE DECISION MADE: 04-JUN-07
SAN DIEGO, CA 92123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARCATH PERIPHERAL DILATATION SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K071042(SPECIAL)
ATTN: MONICA MORRISON PHONE NO : 763-494-2676
ONE SCIMED PLACE SE DECISION MADE: 13-JUN-07
MAPLE GROVE, MN 55311-1566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPYCATCH STONE RETRIEVAL BASKET
BOSTON SCIENTIFIC CORP. 510(k) NO: K071066(SPECIAL)
ATTN: NEIL KELLY PHONE NO : 508-683-4872
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 29-JUN-07
MAILSTOP M11 510(k) SUMMARY AVAILABLE FROM FDA
MARLBOROUGH, MA 01752
DEVICE: RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0
CALGARY SCIENTIFIC, INC. 510(k) NO: K071086(TRADITIONAL)
ATTN: PIERRE LEMIRE PHONE NO : 403 270 7159
SUITE 208, 1210 20TH AVENUE SE SE DECISION MADE: 01-JUN-07
CALGARY, ALBERTA, CANADA T2G 1M8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
CAMBRIDGE SENSORS LIMITED 510(k) NO: K070524(TRADITIONAL)
ATTN: WARREN REEVES PHONE NO : 004 414 80482920
UNITS 9&10 CARDINAL PARK SE DECISION MADE: 22-JUN-07
GODMANCHESTER 510(k) SUMMARY AVAILABLE FROM FDA
HUNTINGDON, CAMBRIDGESHIRE, UNITED KINGDOM PE29 2XG
DEVICE: CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
CAPINTEC, INC. 510(k) NO: K071396(SPECIAL)
ATTN: MARY ANNE DELL PHONE NO : 412-963-1988
620 ALPHA DR. SE DECISION MADE: 28-JUN-07
PITTSBURGH, PA 15241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIFLEX SELECT
CARDINAL HEALTH, INC. 510(k) NO: K070647(SPECIAL)
ATTN: AMY HOYD PHONE NO : 847-578-2325
1500 WAUKEGAN ROAD SE DECISION MADE: 22-JUN-07
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTACLAMP FLEX
CARDIO LIFE RESEARCH, S.A. 510(k) NO: K070380(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550
220 RIVER ROAD SE DECISION MADE: 08-JUN-07
CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALSTIM EXPERIA
CHATTANOOGA GROUP 510(k) NO: K070425(TRADITIONAL)
ATTN: MICHAEL TREAS PHONE NO : 423-870-2281
4717 ADAMS RD. SE DECISION MADE: 11-JUN-07
HIXSON, TN 37343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
COLOPLAST MANUFACTURING US, LLC 510(k) NO: K070939(SPECIAL)
ATTN: REBEKA STOLTMAN PHONE NO : 800-788-0293
1601 WEST RIVER ROAD SE DECISION MADE: 01-JUN-07
MINNEAPOLIS, MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY
COOLSYSTEMS, INC. 510(k) NO: K071050(TRADITIONAL)
ATTN: MARIANNE BALDWIN PHONE NO : 510-868-5378
2201 DWIGHT WAY SE DECISION MADE: 29-JUN-07
BERKELEY, CA 94704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVOIS IMPLANT SYSTEM
CURASAN AG 510(k) NO: K063106(ABBREVIATED)
ATTN: ERIC WEICHERT PHONE NO : 919-772-8518
109 SHORE DRIVE SE DECISION MADE: 11-JUN-07
GARNER, NC 27529 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISSYS LP SPINAL FIXATION SYSTEM
CUSTOM SPINE, INC. 510(k) NO: K070281(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999
13540 GUILD AVE SE DECISION MADE: 11-JUN-07
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
DADE BEHRING, INC. 510(k) NO: K070853(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
P.O. BOX 6101, M/S 514 SE DECISION MADE: 13-JUN-07
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TET
DADE BEHRING, INC. 510(k) NO: K071268(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 26-JUN-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
DATEX-OHMEDA 510(k) NO: K071142(SPECIAL)
ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551
PO BOX 7550 SE DECISION MADE: 06-JUN-07
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURALAY PIT & FISSURE SEALANT
DENALI CORPORATION 510(k) NO: K071158(TRADITIONAL)
ATTN: JAN G STANNARD PHONE NO : 781-826-9190
134 OLD WASHINGTON STREET SE DECISION MADE: 05-JUN-07
HANOVER, MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
DENTALEZ, INC. 510(k) NO: K070869(TRADITIONAL)
ATTN: WILLIAM GUSCOTT PHONE NO : 717-291-1161
1816 COLONIAL VILLAGE LN. SE DECISION MADE: 15-JUN-07
LANCASTER, PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K071257(TRADITIONAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359
325 PARAMOUNT DR. SE DECISION MADE: 29-JUN-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K070849(TRADITIONAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923
700 ORTHOPAEDIC DR. SE DECISION MADE: 26-JUN-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM 4.5MM SPINE SYSTEM
DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K071495(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852
325 PARAMOUNT DRIVE SE DECISION MADE: 29-JUN-07
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
DERMA CARE PLUS PRODUCTS LLC 510(k) NO: K070760(TRADITIONAL)
ATTN: JOSEPH NEUSER PHONE NO : 920-469-4514
1500 RIVER PINES DRIVE SE DECISION MADE: 07-JUN-07
GREEN BAY, WI 54311 510(k) STATEMENT
DEVICE: SPACE 360 DELIVERY SYSTEM
DFINE, INC. 510(k) NO: K070351(TRADITIONAL)
ATTN: ROBERT POSER PHONE NO : 408-725-1515
19450 STEVENS CREEK BLVD. SE DECISION MADE: 29-JUN-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
CUPERTINO, CA 95014
DEVICE: ENZYMATIC CREATININE ASSAY (265 SERIES)
DIAGNOSTIC CHEMICALS LTD. 510(k) NO: K070383(TRADITIONAL)
ATTN: DEBBIE M MURRAY PHONE NO : 902 566 1396
16 MCCARVILLE ST. SE DECISION MADE: 22-JUN-07
CHARLOTTETOWN, P.E.I., CANADA C1E 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K070566(SPECIAL)
ATTN: MARK KIERAS PHONE NO : 978-379-8219
6 TECH DRIVE SE DECISION MADE: 04-JUN-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900
E-Z-EM, INC. 510(k) NO: K071378(SPECIAL)
ATTN: STEVEN HARTMAN PHONE NO : 516-333-8230
750 SUMMA AVE. SE DECISION MADE: 13-JUN-07
WESTBURY, NY 11590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01
EDWARDS LIFESCIENCES SERVICES GMBH510(k) NO: K070320(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 441 763 222505
BUSINESS & TECHNOLOGY CENTER SE DECISION MADE: 07-JUN-07
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE, HERTSFORDSHIRE, UNITED KINGDOM SG1 2DX
DEVICE: HABIB HEXABLATE
EMCISION, LTD. 510(k) NO: K071103(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 44 208 3838574
LIVER SURGERY, HAMMERSMITH SE DECISION MADE: 27-JUN-07
HOSPITAL CAMPUS, DU CANE RD. 510(k) SUMMARY AVAILABLE FROM FDA
LONDON, UK, UNITED KINGDOM W12 OHSTHIRD PARTY REVIEW
DEVICE: SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
ENGINEERED MEDICAL SOLUTIONS CO. L510(k) NO: K071180(TRADITIONAL)
ATTN: WILLIAM G MCLAIN PHONE NO : 717-656-9656
342E. MAIN STREET, SUITE 211 SE DECISION MADE: 20-JUN-07
LEOLA, PA 17540 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: OSSIPRO BONE SUBSTITUTE MATERIAL
ETEX CORP. 510(k) NO: K062630(TRADITIONAL)
ATTN: FRANCES A FLORENCE PHONE NO : 617-577-7270
38 SIDNEY ST., 3FLR SE DECISION MADE: 28-JUN-07
THE CLARK BLDG. 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139
DEVICE: ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH
ETHICON ENDO-SURGERY, LLC 510(k) NO: K070198(TRADITIONAL)
ATTN: WENDY TURNER PHONE NO : 513-337-8807
4545 CREEK ROAD SE DECISION MADE: 13-JUN-07
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
ETHICON, INC. 510(k) NO: K071249(SPECIAL)
ATTN: PATRICE NAPODA PHONE NO : 908-218-2885
U.S. ROUTE 22, WEST SE DECISION MADE: 05-JUN-07
P.O. BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876-0151
DEVICE: ER35 ERO-SCAN PRO HEARING TEST SYSTEM
ETYMOTIC RESEARCH, INC. 510(k) NO: K070880(TRADITIONAL)
ATTN: CAMPBELL L TUSKEY PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVE. NW SE DECISION MADE: 07-JUN-07
SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
EUROIMMUN US LLC 510(k) NO: K061239(TRADITIONAL)
ATTN: KATHRYN KOHL PHONE NO : 973-402-6101
429 ROCKAWAY VALLEY ROAD SE DECISION MADE: 28-JUN-07
UNIT 1200 510(k) STATEMENT
BOONTON TOWNSHIP, NJ 07005
DEVICE: EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507
EVERLIFE MEDICAL EQUIPMENT CO., LT510(k) NO: K070890(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN STREET SE DECISION MADE: 29-JUN-07
HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTECURE; OPTECURE + CCC
EXACTECH, INC. 510(k) NO: K063685(TRADITIONAL)
ATTN: MARITZA ELIAS PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 07-JUN-07
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEEL-JECT INSULIN SYRINGE
FEEL TECH 510(k) NO: K070917(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 20-JUN-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
FLAEM NUOVA S.P.A. 510(k) NO: K062484(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 08-JUN-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNULATED SCREW
FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K070617(TRADITIONAL)
ATTN: PATRICIA DONNARD PHONE NO : 332 985 56895
ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 14-JUN-07
QUIMER, FRANCE 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODE
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K071387(SPECIAL)
ATTN: JANET C KAY PHONE NO : 781-699-4475
920 WINTER STREET SE DECISION MADE: 15-JUN-07
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THD
G.F. S.R.L. 510(k) NO: K070815(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 20-JUN-07
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND
GE HEALTHCARE 510(k) NO: K071020(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 18-JUN-07
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE LUNAR BODY COMPOSITION SOFTWARE
GE MEDICAL SYSTEMS LUNAR 510(k) NO: K071570(TRADITIONAL)
ATTN: JAMES P RASKOB PHONE NO : 608-826-7425
726 HEARTLAND TRAIL SE DECISION MADE: 27-JUN-07
MADISON, WI 53717 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CERADRILL
GEBR. BRASSELER GMBH & CO. KG 510(k) NO: K071352(TRADITIONAL)
ATTN: OLAF BRAND PHONE NO : 495 261 701467
TROPHAGENER WEG 25 SE DECISION MADE: 29-JUN-07
LEMGO, GERMANY D-32657 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, B
GENEXEL-SEIN, INC. 510(k) NO: K071523(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 26-JUN-07
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
GEREONICS, INC. 510(k) NO: K062883(TRADITIONAL)
ATTN: GERALD ROST PHONE NO : 800-654-6266
244 LA BARRANCA DRIVE SE DECISION MADE: 13-JUN-07
SOLANA BEACH, CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
GIVEN IMAGING LTD. 510(k) NO: K071153(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 403 208 4916
91 ROCKYSPRING CIRCLE NW SE DECISION MADE: 11-JUN-07
CALGARY, ALBERTA, CANADA T3G 6A1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON SPECTROSCOPY PACKAGE
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K071506(ABBREVIATED)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 28-JUN-07
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA T
HORIBA ABX 510(k) NO: K060434(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 05-JUN-07
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
HORIBA ABX 510(k) NO: K062737(TRADITIONAL)
ATTN: TIM LAWTON PHONE NO : 334 671 47320
PARC EUROMEDECINE SE DECISION MADE: 12-JUN-07
RUE DU CADUCEE 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, HERAULT, FRANCE 34184
DEVICE: TRIATHLON TS KNEE SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K070095(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR. SE DECISION MADE: 01-JUN-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
HU-FRIEDY MFG. CO., INC 510(k) NO: K070975(TRADITIONAL)
ATTN: KEITH DUNN PHONE NO : 773-975-3975
3232 N. ROCKWELL STREET SE DECISION MADE: 21-JUN-07
CHICAGO, IL 60618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENIE, MODEL CH-200
ICU MEDICAL, INC 510(k) NO: K070633(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332
4455 ATHERTON DR. SE DECISION MADE: 05-JUN-07
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K071401(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
2340 PEGASUS WAY, NE SE DECISION MADE: 22-JUN-07
SUITE 151 510(k) SUMMARY AVAILABLE FROM FDA
CALGARY, CANADA T2E 8M5
DEVICE: X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K071402(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
2340 PEGASUS WAY, NE SE DECISION MADE: 08-JUN-07
SUITE 151 510(k) SUMMARY AVAILABLE FROM FDA
CALGARY, CANADA T2E 8M5
DEVICE: X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K071403(SPECIAL)
ATTN: SHIRANTHAN SAMARAPPULI PHONE NO : 403 251 9939
2340 PEGASUS WAY, NE SE DECISION MADE: 11-JUN-07
SUITE 151 510(k) SUMMARY AVAILABLE FROM FDA
CALGARY, CANADA T2E 8M5
DEVICE: X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K071408(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
2340 PEGASUS WAY, NE SE DECISION MADE: 13-JUN-07
SUITE 151 510(k) SUMMARY AVAILABLE FROM FDA
CALGARY, CANADA T2E 8M5
DEVICE: X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
IMAGING DYNAMICS COMPANY LTD. 510(k) NO: K071409(SPECIAL)
ATTN: SHIRANTHA SAMARAPPULI PHONE NO : 403 251 9939
2340 PEGASUS WAY, NE SE DECISION MADE: 08-JUN-07
SUITE 151 510(k) SUMMARY AVAILABLE FROM FDA
CALGARY, CANADA T2E 8M5
DEVICE: OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN P
IMPLANT INNOVATIONS, INC. 510(k) NO: K062636(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 01-JUN-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
INNOVA VISION INC. 510(k) NO: K062541(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-853-6340
2904 N. BOLDT DR SE DECISION MADE: 07-JUN-07
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA PLEX CELIAC IGA PROFILE
INOVA DIAGNOSTICS, INC. 510(k) NO: K063818(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 20-JUN-07
SAN DIEGO, CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NARROW NECK TEMPORARY COPING
INSTITUT STRAUMANN AG 510(k) NO: K070744(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 29-JUN-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K071458(SPECIAL)
ATTN: DONNA WALLACE PHONE NO : 609-936-2397
311 ENTERPRISE DR. SE DECISION MADE: 13-JUN-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
INTERACOUSTICS A/S 510(k) NO: K070696(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-941-4200
7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 29-JUN-07
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K-JUMP HEALTH CO., LTD. 510(k) NO: K070491(ABBREVIATED)
ATTN: DANIEL WANG PHONE NO : 011 886 222991378
NO. 56, WU KUNG 5TH RD., SE DECISION MADE: 21-JUN-07
WU KU INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI HSIEN, CHINA (TAIWAN) 248
DEVICE: V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
KCI USA, INC. 510(k) NO: K063692(TRADITIONAL)
ATTN: MARGARET MARSH PHONE NO : 210-255-6481
8023 VANTAGE DR. SE DECISION MADE: 07-JUN-07
SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M625776
KCI USA, INC. 510(k) NO: K063740(TRADITIONAL)
ATTN: MARGARET MARSH PHONE NO : 210-255-6481
8023 VANTAGE DR. SE DECISION MADE: 07-JUN-07
SAN ANTONIO, TX 78230-4726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPIOS BONE VOID FILLER SPONGE AND PASTE
KENSEY NASH CORP. 510(k) NO: K071237(SPECIAL)
ATTN: JENNIFER J BOSLEY PHONE NO : 484-713-2173
735 PENNSYLVANIA DRIVE SE DECISION MADE: 01-JUN-07
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
KODON(TIANJIN)ELECTRONIC&ELECTRICA510(k) NO: K070395(TRADITIONAL)
ATTN: LIU YI PHONE NO : 862 260 528012
NO.31, CHANGJIANG ROAD, SE DECISION MADE: 07-JUN-07
NANKAI DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TIANJIN, CHINA 300193
DEVICE: REGIUS UNITEA
KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K071436(TRADITIONAL)
ATTN: RUSSELL MUNVES PHONE NO : 212-490-4100
140 EAST 45TH ST., 25TH FLOOR SE DECISION MADE: 27-JUN-07
TWO GRAND CENTRAL TOWER 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10017
DEVICE: XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
KUB TECHNOLOGIES, INC 510(k) NO: K071233(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 20-JUN-07
SHELTON, CT 06824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARFIL MAJESTY POSTERIOR PLT
KURARAY MEDICAL INC. 510(k) NO: K071169(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVENUE SE DECISION MADE: 20-JUN-07
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: BLUGOO HD
LANCER ORTHODONTICS, INC. 510(k) NO: K071192(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 22-JUN-07
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARX-LINK CROSS CONNECTOR
LIFE SPINE 510(k) NO: K070995(SPECIAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117
2401 W. HASSELL RD. SE DECISION MADE: 22-JUN-07
SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60169
DEVICE: LRTM SURGICAL MESH
LIFECELL CORP. 510(k) NO: K070560(TRADITIONAL)
ATTN: LORRAINE T MONTEMURRO PHONE NO : 908-947-1115
ONE MILLENNIUM WAY SE DECISION MADE: 11-JUN-07
BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
MASIMO CORPORATION 510(k) NO: K071024(SPECIAL)
ATTN: JAMES J CRONIN PHONE NO : 949-297-7000
40 AND 50 PARKER SE DECISION MADE: 29-JUN-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO PATIENT SAFETY NET
MASIMO CORPORATION 510(k) NO: K071047(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949-297-7258
40 PARKER SE DECISION MADE: 08-JUN-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LMS-LIVER
MEDIAN TECHNOLOGIES 510(k) NO: K071241(TRADITIONAL)
ATTN: CHAS BURR PHONE NO : 781-789-1646
11 MYSTIC AVE. SE DECISION MADE: 08-JUN-07
WINCHESTER, MA 01890-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
MEDICA CORP. 510(k) NO: K063376(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
5 OAK PARK DRIVE SE DECISION MADE: 25-JUN-07
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: MEDICK MHM200 PERSONAL HEART MONITOR
MEDICK HEALTHCARE LTD. 510(k) NO: K063339(TRADITIONAL)
ATTN: JAMES W SANDBERG PHONE NO : 425-891-7347
8303 N.E. JUANITA DRIVE SE DECISION MADE: 29-JUN-07
KIRKLAND, WA 98034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
MEDILINE ITALIA S.R.L. 510(k) NO: K063681(TRADITIONAL)
ATTN: PANTALEONI MAURIZIO PHONE NO : 301-263-0344
6512 BANNOCKBURN DRIVE SE DECISION MADE: 29-JUN-07
BETHESDA, MD 20817 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
MEDIVATORS REPROCESSING SYSTEMS 510(k) NO: K063876(TRADITIONAL)
ATTN: LYNN LUEDERS PHONE NO : 763-553-2475
14605 28TH AVE., NORTH SE DECISION MADE: 14-JUN-07
MINNEAPOLIS, MN 55447-4822 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K063670(SPECIAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 28-JUN-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 6081
MEDTRONIC VASCULAR 510(k) NO: K070288(TRADITIONAL)
ATTN: SCOTT CUNDY PHONE NO : 763-391-9941
7601 NORTHLAND DRIVE SE DECISION MADE: 18-JUN-07
MINNEAPOLIS, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE INHIBITOR, MODEL 001
MELMEDTRONICS, INC. 510(k) NO: K070648(TRADITIONAL)
ATTN: DAVID W HOLMES PHONE NO : 817-268-1564
1550 NORWOOD DR., SUITE 100 SE DECISION MADE: 29-JUN-07
HURST, TX 76054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K070159(SPECIAL)
ATTN: JERRIE HENDRICKSON PHONE NO : 801-208-4119
1600 WEST MERIT PKWY. SE DECISION MADE: 21-JUN-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASSAGE MATTRESS VM9100RM
METEK GMBH 510(k) NO: K070672(TRADITIONAL)
ATTN: STEFAN ZIEGENFUB PHONE NO : 49 360 551590
STAMMWEG 8 SE DECISION MADE: 26-JUN-07
LEINEFELDE, GERMANY 37327 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HYDROCOIL EMBOLIC SYSTEM (HES)
MICROVENTION, INC. 510(k) NO: K070656(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-951-0505
75 COLUMBIA SE DECISION MADE: 15-JUN-07
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K071246(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 01-JUN-07
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL
NEOCOIL 510(k) NO: K071611(TRADITIONAL)
ATTN: BRIAN BROWN PHONE NO : 262-347-1250
N27 W23910A PAUL RD. SE DECISION MADE: 28-JUN-07
PEWAUKEE, WI 53072 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K071058(SPECIAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 29-JUN-07
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
NOVA BIOMEDICAL CORP. 510(k) NO: K070255(TRADITIONAL)
ATTN: PAUL W MACDONALD, PHD PHONE NO : 781-894-0800
200 PROSPECT ST. SE DECISION MADE: 13-JUN-07
WALTHAM, MA 02454-9141 510(k) STATEMENT
DEVICE: REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
NOVARE SURGICAL SYSTEMS, INC. 510(k) NO: K071488(SPECIAL)
ATTN: GREGORY MATHISON PHONE NO : 218-387-1559
3924 CASCADE BEACH RD. SE DECISION MADE: 29-JUN-07
LUTSEN, MN 55612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMDX SYSTEMS
NOVX SYSTEMS INC. 510(k) NO: K063699(TRADITIONAL)
ATTN: THOMAS TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 01-JUN-07
ROCKVILLE, MD 20853 510(k) STATEMENT
DEVICE: OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRA
OLYMPUS LIFE & MATERIAL SCIENCE EU510(k) NO: K070453(TRADITIONAL)
ATTN: STEPHANIE G SCHWARTZ PHONE NO : 469-230-0959
3131 WEST ROYAL LANE SE DECISION MADE: 11-JUN-07
IRVING, TX 75063-3104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS CK-MB REAGENT
OLYMPUS LIFE & MATERIAL SCIENCE EU510(k) NO: K070835(TRADITIONAL)
ATTN: STEPHANIE G SCHWARTZ PHONE NO : 469-230-0959
LISMEEHAN SE DECISION MADE: 04-JUN-07
O'CALLAGHANS MILLS, CO. CLARE, IRE510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY
OPTIKEM INTERNATIONAL, INC. 510(k) NO: K071203(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
2214 SANFORD DRIVE UNIT B7 SE DECISION MADE: 13-JUN-07
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRODE/EXTENSION CABLES, MODELS ATAR
OSCOR INC. 510(k) NO: K070926(SPECIAL)
ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511
3816 DE SOTO BLVD. SE DECISION MADE: 07-JUN-07
PALM HARBOR, FL 34683 510(k) STATEMENT
DEVICE: OTOMEDICS SOFT TYMPANOSTOMY TUBE
OTOMEDICS ADVANCED MEDICAL TECHNOL510(k) NO: K071178(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 9 7670002
20 HATA'AS ST. SE DECISION MADE: 22-JUN-07
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAJUNKS EPILONG SET PEDIATRIC
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K062902(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291586
KARL-HALL-STRASSE 1 SE DECISION MADE: 07-JUN-07
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALM ECG RECORDER, MODEL EP-201/202
PARAMA-TECH COMPANY., LTD 510(k) NO: K061123(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700
1151 HOPE STREET SE DECISION MADE: 29-JUN-07
STAMFORD, CT 06907-1659 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITE BIOMATRIX
PEGASUS BIOLOGICS, INC. 510(k) NO: K071425(SPECIAL)
ATTN: PAMELA MISAJON PHONE NO : 949-502-3240
6 JENNER SE DECISION MADE: 20-JUN-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92618
DEVICE: AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN
PENTRON CERAMICS, INC. 510(k) NO: K070699(ABBREVIATED)
ATTN: MEGAN VERNAK PHONE NO : 732-563-4755
500 MEMORIAL DR. SE DECISION MADE: 29-JUN-07
SOMERSET, NJ 08873 510(k) STATEMENT
DEVICE: GENESISCS COMPONENT CONCENTRATING SYSTEM
PERFUSION PARTNERS & ASSOC. INC. 510(k) NO: K070666(TRADITIONAL)
ATTN: NANCY LORD MD. ESQ PHONE NO : 775-253-0137
1970 N. LESLIE RD., NO 220 SE DECISION MADE: 20-JUN-07
PAHRUMP, NV 89060 510(k) STATEMENT
DEVICE: MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K071426(SPECIAL)
ATTN: MARKUS STACHA PHONE NO : 497 031 4632810
HEWLETT-PACKARD STR.2 SE DECISION MADE: 13-JUN-07
BOEBLINGEN, BADEN-WUERTTEMBERG, GE510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYMAP PWR-08-03
POLYMAP WIRELESS 510(k) NO: K070559(ABBREVIATED)
ATTN: PIERRE LANDAU PHONE NO : 520-747-1811
310 S. WILLIAMS BLVD, STE. 346 SE DECISION MADE: 29-JUN-07
TUCSON, AZ 85711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRACE DUAL CURE COMPOSITE MATERIALS
PULPDENT CORPORATION 510(k) NO: K071278(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617-926-6666
80 OAKLAND ST. SE DECISION MADE: 29-JUN-07
WATERTOWN, MA 02472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED LATEX EXAMINATION GLOVES
QUALITY GALLANT SDN. BHD. 510(k) NO: K071323(TRADITIONAL)
ATTN: SEAH B HOON PHONE NO : 605 849 4931
LOT 1874, JALAN KAMPUNG DEW SE DECISION MADE: 22-JUN-07
SIMPANG HALT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPING, PERAK, MALAYSIA 34700
DEVICE: REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
RADIANT MEDICAL 510(k) NO: K071358(TRADITIONAL)
ATTN: SCOTT A WILSON PHONE NO : 650-298-0748
250 CHESAPEAKE DR. SE DECISION MADE: 01-JUN-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEALINK
RESMED GERMANY INC. 510(k) NO: K070263(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 15-JUN-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
RG MEDICAL DIAGNOSTICS 510(k) NO: K070878(TRADITIONAL)
ATTN: RONALD G LE TOURNEAU PHONE NO : 248-758-0181
21130 BRIDGE STREET SE DECISION MADE: 05-JUN-07
SOUTHFIELD, MI 48034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: INTERPLATE VBR SYSTEM
RSB SPINE LLC. 510(k) NO: K071372(SPECIAL)
ATTN: KAREN WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 11-JUN-07
CHESTERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
SA SCIENTIFIC LTD. 510(k) NO: K061496(TRADITIONAL)
ATTN: RICARDO R MARTINEZ PHONE NO : 210-699-8800
4919 GOLDEN QUAIL SE DECISION MADE: 28-JUN-07
SAN ANTONIO, TX 78240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SACS EEG WORKSTATION A7
SACS MEDICAL AB 510(k) NO: K071109(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 541-683-3017
3684 NORTH SHASTA LOOP SE DECISION MADE: 07-JUN-07
EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOWTOP PEDICLE SCREW SYSTEM
SANACOR 510(k) NO: K070933(TRADITIONAL)
ATTN: MICHAEL ENSIGN PHONE NO : 801-756-8255
765 EAST 340 SOUTH, SE DECISION MADE: 13-JUN-07
SUITE 204 510(k) SUMMARY AVAILABLE FROM FDA
AMERICAN FORK, UT 84003
DEVICE: HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
SEBIA 510(k) NO: K063498(TRADITIONAL)
ATTN: KAREN ANDERSON PHONE NO : 800-835-6497
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-JUN-07
GREAT NECK, NY 11001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPICAL APPLICATOR
SHARN, INC. 510(k) NO: K070596(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. # 102 SE DECISION MADE: 21-JUN-07
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BC-3200 AUTO HEMATOLOGY ANALYZER
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K063407(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-JUN-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 E
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K070791(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 26-JUN-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH PO
SIAM SEMPERMED CORP. LTD. 510(k) NO: K070639(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250
13900 49TH STREET NORTH SE DECISION MADE: 15-JUN-07
CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-1
SICEL TECHNOLOGIES, INC. 510(k) NO: K071399(SPECIAL)
ATTN: TAMMY B CARREA PHONE NO : 919-465-2236
3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 20-JUN-07
SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SYNGO CT ONCOLOGY SOFTWARE PACKAGE
SIEMENS AG 510(k) NO: K071310(TRADITIONAL)
ATTN: KRISTIN FROWEIN PHONE NO : 499 191 189638
SIEMENSSTRASSE 1 SE DECISION MADE: 08-JUN-07
FORCHHEIM, GERMANY 91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
SIEMENS HEARING INSTRUMENTS, INC. 510(k) NO: K071462(TRADITIONAL)
ATTN: JON SCHIRADO PHONE NO : 763-268-4605
10 CONSTITUTION AVE. SE DECISION MADE: 05-JUN-07
P.O. BOX 1397 510(k) SUMMARY AVAILABLE FROM FDA
PISCATAWAY, NJ 08855 THIRD PARTY REVIEW
DEVICE: INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
SIEMENS MEDICAL SOLUTIONS 510(k) NO: K071513(TRADITIONAL)
ATTN: RALF HOFMANN PHONE NO : 49 919 1188170
SIEMENSSTRASSE 1 SE DECISION MADE: 26-JUN-07
FORCHHEIM, GERMANY D-91301 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NORAS OR HEAD HOLDER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071179(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 13-JUN-07
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K071234(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 29-JUN-07
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: MODIFICATION TO:SBI RINGFIX
SMALL BONE INNOVATIONS INC. 510(k) NO: K071394(SPECIAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVE., 14TH FLOOR SE DECISION MADE: 29-JUN-07
NEW YORK, NY 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K070756(SPECIAL)
ATTN: NICHOLAS TABRIZI PHONE NO : 901-399-6017
1450 BROOKS RD. SE DECISION MADE: 06-JUN-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSSEOUS DENTAL IMPLANT SYSTEM
SOUTHERN IMPLANTS, INC. 510(k) NO: K070841(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 703-278-3953
10355 B DEMOCRACY LANE SE DECISION MADE: 21-JUN-07
FAIRFAX, VA 22030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMILOC (TM) SAFETY INTRODUCER NEEDLE
SPECIALIZED HEALTH PRODUCTS INTERN510(k) NO: K070449(TRADITIONAL)
ATTN: MARK NELSON PHONE NO : 801-298-3360
586 WEST 500 SOUTH #200 SE DECISION MADE: 14-JUN-07
SALT LAKE, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMS GLUCOSE CONTROL, MODEL 2120059
SPECIALTY MEDICAL SUPPLIES 510(k) NO: K071433(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 28-JUN-07
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILICONE TISSUE EXPANDER
SPECIALTY SURGICAL PRODUCTS 510(k) NO: K070303(TRADITIONAL)
ATTN: ANGELA LAWRENCE PHONE NO : 406-961-0102
1131 US HIGHWAY 93 NORTH SE DECISION MADE: 22-JUN-07
VICTOR, MT 59875 510(k) STATEMENT
DEVICE: 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-
SPECTRANETICS CORP. 510(k) NO: K071226(TRADITIONAL)
ATTN: MICHAEL K HANDLEY PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 29-JUN-07
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980
ST. JUDE MEDICAL 510(k) NO: K070417(TRADITIONAL)
ATTN: LAURA MOEN-FTACEK PHONE NO : 952-933-4700
14901 DEVEAU PL. SE DECISION MADE: 05-JUN-07
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT NEURO N50, MODEL12267
STOCKERT GMBH 510(k) NO: K070336(TRADITIONAL)
ATTN: DOMINIKA SCHULER PHONE NO : 497 612 07160
BOETZINGER STRASSE 72 SE DECISION MADE: 14-JUN-07
FREIBURG, B-W, GERMANY D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNMED FOLEY CATHETERS
SUNMED, INC. 510(k) NO: K062112(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 04-JUN-07
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULCELOOCIN ORAL ULCER PATCH
SUNSHINE INTERNATIONAL GROUP, INC.510(k) NO: K070842(TRADITIONAL)
ATTN: LIPING HE PHONE NO : 212-268-7771
1333 BROADWAY SE DECISION MADE: 07-JUN-07
SUITE 1222 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10018
DEVICE: SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIU
SYNTHES (USA) 510(k) NO: K070946(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY SE DECISION MADE: 06-JUN-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP)
SYNTHES (USA) 510(k) NO: K071184(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301-1303 GOSHEN PKWY. SE DECISION MADE: 22-JUN-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNAPSE SYSTEM
SYNTHES SPINE CO.LP 510(k) NO: K070573(SPECIAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5733
1302 WRIGHTS LANE EAST SE DECISION MADE: 08-JUN-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K070941(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 266 358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 21-JUN-07
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLU
THE BINDING SITE, LTD. 510(k) NO: K062372(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 21-JUN-07
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
THEKEN SPINE LLC 510(k) NO: K070786(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-773-7677
283 E WATERLOO RD. SE DECISION MADE: 28-JUN-07
AKRON, OH 44319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMAGE THERMACOOL SYSTEM
THERMAGE, INC. 510(k) NO: K052936(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116
25881 INDUSTRIAL BLVD. SE DECISION MADE: 12-JUN-07
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K071232(SPECIAL)
ATTN: INGE SCHEIDT PHONE NO : 49 893 2175515
EDISONSTRASSE 6 SE DECISION MADE: 20-JUN-07
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
TOPCON CORP. 510(k) NO: K063388(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600
555 THIRTEENTH STREET NW SE DECISION MADE: 22-JUN-07
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004
DEVICE: MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
TOPSPINS, INC. 510(k) NO: K071140(TRADITIONAL)
ATTN: ERIN BUETHE PHONE NO : 512-658-5729
403 RIVERVIEW DR SE DECISION MADE: 07-JUN-07
ANN ARBOR, MI 48107-7205 510(k) STATEMENT
DEVICE: ST AIA-PACK INTACT PTH ASSAY
TOSOH BIOSCIENCE, INC. 510(k) NO: K063605(TRADITIONAL)
ATTN: CHARLES P GILL PHONE NO : 614-317-1909
3600 GANTZ ROAD SE DECISION MADE: 21-JUN-07
GROVE CITY, OH 43123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRAEZ DESENSITIZING GEL
ULTRADENT PRODUCTS, INC. 510(k) NO: K061438(TRADITIONAL)
ATTN: TAMMY LAVERY PHONE NO : 801-553-4200
505 WEST 10200 SOUTH SE DECISION MADE: 12-JUN-07
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTICAL GUIDANCE PLATFORM
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K071360(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 08-JUN-07
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CAT
VASCULAR SOLUTIONS, INC. 510(k) NO: K070372(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4228
6464 SYCAMORE COURT SE DECISION MADE: 01-JUN-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTO .035" EXTRACTION CATHETER
VASCULAR SOLUTIONS, INC. 510(k) NO: K070403(TRADITIONAL)
ATTN: DORALIE POGANSKI PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 13-JUN-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
VERTEBRON, INC. 510(k) NO: K071376(SPECIAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340
400 LONG BEACH BLVD. SE DECISION MADE: 13-JUN-07
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
VIASYS SLEEP SYSTEMS, LLC. 510(k) NO: K071069(TRADITIONAL)
ATTN: KEITH BOSECKER PHONE NO : 818-341-4131
9305 ETON AVENUE SE DECISION MADE: 12-JUN-07
CHATSWORTH, CA 91311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM SCALLOPED ABUTMENT
VIDENT 510(k) NO: K063768(TRADITIONAL)
ATTN: ELIZABETH WOLFSEN PHONE NO : 714-961-6200
3150 EAST BIRCH ST. SE DECISION MADE: 27-JUN-07
BREA, CA 92821 510(k) STATEMENT
DEVICE: VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102,
VITA 510(k) NO: K070991(TRADITIONAL)
ATTN: ELIZABETH WOLFSEN PHONE NO : 714-961-6200
3150 E.BIRCH ST SE DECISION MADE: 01-JUN-07
BREA, CA 92821 510(k) STATEMENT
DEVICE: BONALIVE GRANULES AND BONALIVE PLATES
VIVOXID LTD. 510(k) NO: K070055(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 25-JUN-07
FRIDLEY, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUTURABOND DC/SINGLE DOSE
VOCO GMBH 510(k) NO: K070723(TRADITIONAL)
ATTN: THORSTEN GERKENSMEIER PHONE NO : 490 472 1719200
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 07-JUN-07
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: AMARIS/AMARIS FLOW
VOCO GMBH 510(k) NO: K071386(SPECIAL)
ATTN: MANFRED THOMAS PLAUMANN PHONE NO : 490 472 17190
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 05-JUN-07
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: GORE BALLOON SHEATH
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K070770(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 925-209-7174
2647 LIN GATE COURT SE DECISION MADE: 29-JUN-07
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROXENON 350, MODEL 902XX
WELCH ALLYN, INC. 510(k) NO: K071218(TRADITIONAL)
ATTN: JOHN E SAWYER PHONE NO : 315-685-4571
4341 STATE STREET ROAD SE DECISION MADE: 14-JUN-07
PO BOX 220 510(k) SUMMARY AVAILABLE FROM FDA
SKANEATELES FALLS, NY 13153-0220
DEVICE: STERILIZATION POUCH WITH INDICATORS
WINNER INDUSTRIES (SHENZHEN) CO., 510(k) NO: K062704(TRADITIONAL)
ATTN: MING XIE PHONE NO : 909-465-0598
1O37 WALNUT AVE. SE DECISION MADE: 08-JUN-07
POMONA, CA 91766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE,
WRP ASIA PACIFIC SDN. BHD. 510(k) NO: K070619(SPECIAL)
ATTN: KIRK PENNER PHONE NO : 603 870 61486
LOT1,JALAN3,KAWASAN PERUSAHAAN SE DECISION MADE: 27-JUN-07
BANDAR BARU SALAK TINGGI 510(k) SUMMARY AVAILABLE FROM FDA
SEPANG,SELANGOR DARUL EHSAN, MALAYSIA 43900
DEVICE: NASOPHARYNGOSCOPE, BRONCHOSCOPE
XION GMBH 510(k) NO: K070580(TRADITIONAL)
ATTN: ALEXANDER KLIEM PHONE NO : 490 304 7498756
PANKSTR. 8-10 SE DECISION MADE: 13-JUN-07
BERLIN, GERMANY 13127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALTH CHECK KIOSK
XPEREX CORPORATION 510(k) NO: K063008(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 07-JUN-07
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASA01 HEAVY DUTY SUCTION PUMP
ZHONGSHAN A&J MEDICAL EQUIPMENT CO510(k) NO: K071607(TRADITIONAL)
ATTN: POLO CHEN PHONE NO : 86 760 3133726
3 SHENGHUI SOUTH ROAD SE DECISION MADE: 26-JUN-07
NANTOU TOWN, ZHONGSHAN CITY 510(k) SUMMARY AVAILABLE FROM FDA
GUANGDONG, CHINA THIRD PARTY REVIEW
DEVICE: TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION
ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K071090(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 973-576-0139
10 POMEROY RD. SE DECISION MADE: 29-JUN-07
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
ZIMMER, INC. 510(k) NO: K070695(TRADITIONAL)
ATTN: DALENE BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 07-JUN-07
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K071025(SPECIAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171
269 MILL ROAD SE DECISION MADE: 22-JUN-07
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 217
TOTAL WITH SUMMARIES 201
TOTAL WITH STATEMENTS 16
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