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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 36 Results
ProductCode: OMP Applicant: KCI USA, INC. Decision Date To: 12/08/2021
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abthera open abdomen negative pressure therapy system KCI USA, INC. (KINETIC CONCEPTS, INC.) K120499 10/05/2012
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
v.a.c. 125 negative pressure wound therapy unit KCI USA, INC. K111280 07/21/2011
v.a.c. veraflo cleanse dressing system KCI USA, INC. (KINETIC CONCEPTS, INC.) K103156 03/14/2011
v.a.c. granufoam silver small dressing; v.a.c. granufoam silver medium dressing; v.a.c. granufoam silver large dressing KCI USA, INC. (KINETIC CONCEPTS, INC.) K102956 12/15/2010
v.a.c. ulta negative pressure wound therapy system (v.a.c. ulta therapy system) model v.a.c. ulta therapy unit model u KCI USA, INC. (KINETIC CONCEPTS, INC.) K100657 09/17/2010
prevena incision management system KCI USA, INC. K100821 06/11/2010
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
vac therapy system, models 340000, m8259999, 320000, m8259968 and 320100 KCI USA, INC. K091585 12/29/2009
open abdomen negative pressure therapy system, model 370502, canister, model 370510 KCI USA, INC. K083357 03/04/2009
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