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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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Decision
Date
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c change solution warmer C CHANGE SURGICAL LLC k051819 08/15/2005
kd-768 wrist measurement electronic blood pressure monitor KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., k051847 01/05/2006
synthes 4.5 mm lcp straight reconstruction plates SYNTHES (USA) k051986 09/08/2005
omron automatic blood pressure monitor, model hem-711ac OMRON HEALTHCARE, INC. k052154 09/08/2005
in vision gold with spin vision, model 891 sv VOLCANO CORPORATION k052348 12/02/2005
dar-8000f SHIMADZU MEDICAL SYSTEMS k052500 10/17/2005
breathkey model g10/breathkey model g30x OMEGAPOINT SYSTEMS, LLC k052804 12/09/2005
21.3inch monochrome lcd monitor NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. k052942 12/27/2005
fraxel sr laser system RELIANT TECHNOLOGIES, INC. k053047 03/20/2006
biopure mtad root canal cleanser DENTSPLY INTL., INC. k053167 12/08/2005

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