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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 36 Results
ProductCode: OMP Applicant: KCI USA, INC. Decision Date To: 12/08/2021
 
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prevena plus incision management system (no ag); prevena plus duo incision management system (no ag) KCI USA, Inc. K190697 11/22/2019
v.a.c. dermatac drape KCI USA, Inc. K181505 03/28/2019
activ.a.c. therapy unit KCI USA, Inc. K183543 03/20/2019
prevena restor(tm) incision management system KCI USA, Inc. K181507 02/15/2019
prevena plus incision management system, prevena plus duo incision management system KCI USA, Inc. K180855 06/01/2018
prevena plus incision management system, prevena plus duo incision management system KCI USA, INC. K173426 03/09/2018
v.a.c.via 7 day therapy system kit, v.a.c.via therapy starter kit, v.a.c.via negative pressure wound therapy unit KCI USA, Inc. K173447 03/02/2018
v.a.c.ulta negative pressure wound therapy system KCI USA, Inc. (Kinetic Concepts, Inc.) K162790 01/26/2017
v.a.c. rx4 negative pressure wound therapy (npwt) system KCI USA, Inc. K160487 12/09/2016
prevena duo, prevena plus duo incision management systems with peel & place dressings KCI USA, INC. (KINETIC CONCEPTS, INC.) K161897 10/04/2016
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