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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
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aesculap-miethke shunt system gravity assisted valve (gav) AESCULAP, INC. k031303 06/04/2003
aft system proficiency testing program CALBIOCHEM-BEHRING CORP. k820088 01/26/1982
ag foam dressing non-adhesive, ag foam dressing adhesive, silicone ag foam dressing, silicone ag foam dressing with border Winner Medical Co., Ltd. k191819 05/14/2020
akro-sil foley kit 5cc LATEX IND., INC. k771651 09/20/1977
alivecor heart monitor ALIVECOR, INC. k130409 09/06/2013
alphenix, infx-8000v/b, v8.0 Canon Medical Systems Corporation k181670 07/25/2018
amplifier, photopulse, model pa13 MEDSONICS k770332 02/24/1977
amt therapeutic table, model 748amt AMT MFG., INC. k001401 07/12/2000
anametric tibial component metal tray HOWMEDICA CORP. k790348 03/06/1979
anatomic peek ptc cervical fusion system MEDTRONIC SOFAMOR DANEK USA, INC. k133653 04/28/2014

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