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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name negative pressure wound therapy powered suction pump
510(k) Number K141017
Device Name PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
Applicant
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Applicant Contact MARGARET MARSH
Correspondent
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Correspondent Contact MARGARET MARSH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/21/2014
Decision Date 08/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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