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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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labralink suture anchor with inserter, 2.9mm per-loaded with one (1) and (2) #2 uhmwpe suture CAYENNE MEDICAL, INC. k112960 01/09/2012
unity toatal knee system CORIN U.S.A. k113060 09/10/2012
avivo mobile patient management CORVENTIS, INC. k113187 01/04/2012
elittech clinical systems alp ifcc sl ELITECHGROUP k113269 12/29/2011
hologic visceral fat software HOLOGIC, INC. k113356 03/06/2012
vignet telehealth manager VIGNET INC. k113446 07/16/2012
lexus anterior cervical plate system L&K BIOMED CO., LTD k113509 01/20/2012
mta-fillapex PAXMED INTERNATIONAL k113568 08/21/2012
healite ii system LUTRONIC CORPORATION k113668 06/19/2012
v2.6 software for the labsystem pro ep recording system C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION k113811 03/16/2012

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