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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 K150006
Device Name Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
Applicant
KCI USA, INC.
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Applicant Contact MELANIE AVILA
Correspondent
KCI USA, INC.
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Correspondent Contact MELANIE AVILA
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/02/2015
Decision Date 11/06/2015
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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