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U.S. Department of Health and Human Services

510(K) Premarket Notification
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aequalis shoulder fracture system, aequalis reversed shoulder prosthesis, aequalis reversed fracture shoulder prothesis Tornier S.A.S. k131231 10/16/2013
classic intermittent catheter Flexicare Medical, Ltd. k132619 10/11/2013
disposable neutral electrode gp202 Cathay Manufacturing Corp. k130027 08/22/2013
thermo scientific qms tacrolimus assay and calibrators Microgenics Corp. k123343 07/11/2013
ambio remote health monitoring system Arrayent Health, LLC D/B/A Ambio Health k130676 07/08/2013
vasopouse deep vein thrombosis compression device model ipcs, model sqs Caremed Supply, Inc. k122873 01/15/2013
interlink system buretrol solution sets, interlink system buretrol solution sets, continued, clearlink system buretrol s Baxter Healthcare Corp k123874 01/10/2013
intuitive surgical onsite for da vinci surgical systems Intuitive Surgical, Inc. k121921 10/25/2012
xn cal Streck k120745 10/19/2012
reprocessed surgical electric instrument Sterilmed, Inc. k120040 10/05/2012

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