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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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the saver kit Myocure, Inc. k863666 10/20/1986
the titanium fixation system Biomedics k943071 01/06/1995
thermage thermacool ii system Thermage, Inc. k003183 12/08/2000
thermage thermacool system Thermage, Inc. k000944 07/19/2000
thermo scientific qms tacrolimus assay and calibrators Microgenics Corp. k123343 07/11/2013
thromborel s Dade Behring, Inc. k003870 02/20/2001
thyroglobulin autoantibody immunoassay kit Nichols Institute k930777 04/08/1993
ticarcillin/clavulanic acid 2 Ab Biodisk k951879 07/07/1995
tigr matrix surgical mesh Novus Scientific AB k163005 07/27/2017
tono-pen tonometer tip cover Tra & Accessories k033146 11/23/2004

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