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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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modification to proxis system ST. JUDE MEDICAL k073563 01/31/2008
olympus total bhcg test systen OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) k080094 09/03/2008
easyqc - chemistry with electrolytes; chemistry; electrolytes kit; chemistry calibrator, crea-u claibrator MEDICA CORP. k080404 03/13/2009
hlm tubing set with bioline coating MAQUET CARDIOPULMONARY AG k080592 09/11/2008
zen program (mind 440 hearing aid) WIDEX HEARING AID CO., INC. k080955 06/27/2008
dimension vista system a2mac flex reagent cartridge, dimension vista system protein 1 calibrator, dimension vista sysyem DADE BEHRING, INC. k081249 07/21/2008
finger pulse oximeter, model 9560 NONIN MEDICAL, INC. k081285 06/05/2008
olympus afp - alpha-fetoprotein OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) k081709 03/16/2009
circulator boot CIRCULATOR BOOT CORP. k082134 05/07/2009
graftys hbs GRAFTYS k082498 02/25/2009

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