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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 36 Results
ProductCode: OMP Applicant: KCI USA, INC. Decision Date To: 12/08/2021
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v.a.c. veraflo cleanse dressing system KCI USA, INC. (KINETIC CONCEPTS, INC.) K103156 03/14/2011
v.a.c. via therapy system, v.a.c. via negative pressure therapy unit, v.a.c. via dressing (containing v.a.c. granufoam d KCI USA, INC. (KINETIC CONCEPTS, INC.) K093526 03/10/2010
v.a.c.ulta negative pressure wound therapy system KCI USA, Inc. (Kinetic Concepts, Inc.) K162790 01/26/2017
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
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