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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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510(K)
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penumbra smart coil Penumbra, Inc. k143218 03/18/2015
pennine nelaton catheters sizes 5,6,8,10,12,14,16, Pennine Medical , Ltd. k844876 06/05/1985
opus estradiol Pb Diagnostic Systems, Inc. k933066 09/08/1993
opus napa Pb Diagnostic Systems, Inc. k934705 11/22/1993
i-port Patton Medical Devices k052389 09/09/2005
romflex Paraflex Corp. k905718 02/19/1991
pantex am/pm salivary cortisol enzyme immunoassay Pantex, Div. Bio-Analysis, Inc. k102841 05/08/2012
pancoat t4 coated tube radioimmunoassay kit Pantex, Div. Bio-Analysis, Inc. k854324 12/05/1985
pantex fte free testosterone radioimmunoassay kit Pantex, Div. Bio-Analysis, Inc. k862483 01/14/1987
immunocoat progesterone radioimmunoassay kit Pantex, Div. Bio-Analysis, Inc. k894049 09/08/1989

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