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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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Decision
Date
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implantable, multiprogrammable BIOTRONIK SALES, INC. k820774 04/09/1982
in vitro digoxin ria test CLINICAL ASSAYS, INC. k772110 11/22/1977
infill 41-tlif convex oblique device, infill 43-tlif contour oblique, infill 44-tlif contour oblique and the infill 60 PINNACLE SPINE GROUP, LLC k133721 03/31/2014
influenza a & b s-antigen & controls ORION DIAGNOSTICA, INC. k802931 01/12/1981
infrared thermometer Xuzhou Yongkang Electronic Science Technology Co., Ltd k180314 07/11/2018
injection site, code no. 3100 QUEST MEDICAL, INC. k800786 05/08/1980
injector luer, model n34, injector luer lock, model n35, injector luer lock, n35c, connector luer lock, model c35, CARMEL PHARMA AB. k092782 12/07/2009
innervue diagnostic scope system BIOMET ORTHOPEDICS, INC. k072879 01/14/2008
insight bd Siemens Medical Solutions, Inc k172832 02/06/2018
instrument tray pad DEVON INDUSTRIES, INC. k771124 10/28/1977

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