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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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activ.a.c. therapy unit KCI USA, Inc. K183543 03/20/2019
activac therapy unit and infovac therapy unit, vac ats therapy unit and vac freedom therapy unit, vac via therapy unit KCI USA, INC. K120033 05/31/2012
kci npwt gauze dressing KCI USA, INC. K123507 04/04/2013
modification to: v.a.c. granufoam silver protection dressing KCI USA, INC. K053627 02/06/2006
open abdomen negative pressure therapy system, model 370502, canister, model 370510 KCI USA, INC. K083357 03/04/2009
prevena incision management system KCI USA, INC. K100821 06/11/2010
prevena incision management system with peel & place dressing, prevena incision management system with customizable dressing KCI USA, INC. K150006 11/06/2015
prevena plus incision management system (no ag); prevena plus duo incision management system (no ag) KCI USA, Inc. K190697 11/22/2019
prevena plus incision management system kit with peel & place dressing, prevena plus peel & place dressing 5-pack, prevena plus incision management system kit with customizable dressing, prevena plus customizable dressing 5-pack KCI USA, INC. K153199 02/29/2016
prevena plus incision management system, prevena plus duo incision management system KCI USA, INC. K173426 03/09/2018
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