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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 37 Results
ProductCode: OMP Applicant: KCI USA, Inc. Decision Date To: 05/12/2024
 
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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
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. therapy system KCI USA, INC. (KINETIC CONCEPTS, INC.) K062227 10/04/2006
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
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