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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
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3m n95 home respirator with fluid resistance; 3m n95 home respirator 3M COMPANY den060009 05/08/2007
influenza a/h5 (asian lineage) virus real-time rt-pcr primer and probe set CENTERS FOR DISEASE CONTROL AND PREVENTION den060008 02/03/2006
introl cf panel i control MAINE MOLECULAR QUALITY CONTROLS, INC. den060007 10/12/2006
computerized labor monitoring system BARNEV, LTD. den060006 01/30/2007
tephaflex absorbable suture TEPHA, INC. den060003 02/08/2007
inrange remote medication management system INRANGE SYSTEMS, INC. den060002 06/13/2007
phical test GENOVA DIAGNOSTICS den060001 04/26/2006
d-10 hemoglobin a1c program; d-10 dual program BIO-RAD LABORATORIES, INC. k060001 01/20/2006
ritract safety syringe RITRACT LTD. k060002 06/02/2006
excelart vantage zgv TOSHIBA MEDICAL SYSTEMS CORPORATION k060003 01/18/2006

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