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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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v.a.c. via negative pressure wound therapy system KCI USA, INC. K132741 11/15/2013
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
vac therapy system, models 340000, m8259999, 320000, m8259968 and 320100 KCI USA, INC. K091585 12/29/2009
abthera open abdomen negative pressure therapy system KCI USA, INC. (KINETIC CONCEPTS, INC.) K120499 10/05/2012
prevena duo, prevena plus duo incision management systems with peel & place dressings KCI USA, INC. (KINETIC CONCEPTS, INC.) K161897 10/04/2016
prevena incision management system with customizable dressing, prevena incision managemant system with peel& place dres KCI USA, INC. (KINETIC CONCEPTS, INC.) K133232 03/24/2014
prevena incision management system with customizable dressing KCI USA, INC. (KINETIC CONCEPTS, INC.) K123878 01/15/2013
prevena incision management system with customizable dressing, prevena customizable dressing kit KCI USA, INC. (KINETIC CONCEPTS, INC.) K121883 10/11/2012
prevena incision management system with peel & dressing, prevena incision management system with customizable dressing, KCI USA, INC. (KINETIC CONCEPTS, INC.) K141017 08/20/2015
v. a.c. veraflo cleanse choice dressing system for use with the v.a.c. ulta ... KCI USA, INC. (KINETIC CONCEPTS, INC.) K160451 06/20/2016
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