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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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modification to: v.a.c. granufoam silver protection dressing KCI USA, INC. K053627 02/06/2006
v.a.c. therapy system KCI USA, INC. (KINETIC CONCEPTS, INC.) K062227 10/04/2006
v.a.c. ats large (1000 ml) canister with gel, models m6275093/5, m6275093/10 KCI USA, INC. K063426 12/13/2006
v.a.c. freedom canister, model m6275421; v.a.c. ats canister, models k6275422, m6275423 KCI USA, INC. K063590 01/25/2007
v.a.c. therapy systems - info v.a.c. therapy uniy, model m6257766 KCI USA, INC. K063740 06/07/2007
v.a.c. therapy systems-acti v.a.c. therapy unit model# 340000 KCI USA, INC. K063692 06/07/2007
open abdomen negative pressure therapy system, model 370502, canister, model 370510 KCI USA, INC. K083357 03/04/2009
vac therapy system, models 340000, m8259999, 320000, m8259968 and 320100 KCI USA, INC. K091585 12/29/2009
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
prevena incision management system KCI USA, INC. K100821 06/11/2010