FDA 510(k) Decisions During October, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K150694 10/01/2015 3M Comply Hydrogen Peroxide Indicator Tape 1228 3M Company Hilary B. Hovde
K151599 10/02/2015 iSy Implant System Altatec GmbH Colleen Boswell
K143518 10/02/2015 Valeo Spacer System and Valeo II Interbody Fusion Device System Amedica Corp. William D. Jordan
K151615 10/02/2015 TiTHON Staple with OsseoTi Technology BIOMET MANUFACTURING CORP. Patricia Sandborn Beres
K142887 10/01/2015 SIS Inguinal Hernia Repair Graft COOK BIOTECH INCORPRATED Perry W Guinn
K151408 10/02/2015 LOSPA IS Spinal System CORENTEC CO., LTD GOON HEE LEE
K150063 10/02/2015 One Step hCG Pregnancy Test Coretests, Inc. Wen Li
K150892 10/02/2015 CorPath 200 System CORINDUS, INC. Milind Gramopadhye
K151501 10/02/2015 OrthoVis Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS,INC. Justin Baker
K150221 10/01/2015 EPX-4440HD and EPX-4400HD with FICE FUJIFILM MEDICAL SYSTEM U.S.A., INC. MARY MOORE
K152207 10/02/2015 Extended Range Shifter for PROBEAT-V Hitachi,Ltd. , Health Care Company Naoya Nishimura
K151027 10/02/2015 zensor system INTELESENS LIMITED PATRICIA PEPPER
K151949 10/02/2015 Disposable Insulin Syringe JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K150031 10/01/2015 hemoFISH Masterpanel MIACOM DIAGNOSTICS GMBH EVE BLOMEKE
K151011 10/01/2015 VISERA 4K UHD SYSTEM Olympus Medical Systems Corp. Toshiyuki Nakajima
K143515 10/01/2015 Inclusive« Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants PRISMATIK DENTALCRAFT, INC. Brandon Shepard
K152526 10/02/2015 Elecsys Progesterone III CalSet ROCHE DIAGNOSTICS Patty Bates
K150754 10/02/2015 ARGOS SANTEC CORPORATION CHANGHO CHONG
K152545 10/02/2015 DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K143655 10/02/2015 SICAT OPTIMOTION SICAT GMBH & CO. KG MANFRED BREUER
K152177 10/01/2015 SonoStik IV Guide Wire Introducer SONOSTIK, LLC RICHARD FOGEL
K151952 10/01/2015 Synergy ODM TOPCON MEDICAL SYSTEMS, INC. Michael Gusel
K152523 10/01/2015 JBAIDS Influenza A & B Detection Kit U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY ROBERT E MILLER


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