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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 K153199
Device Name Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
Applicant
KCI USA, INC.
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Applicant Contact MARGARET MARSH
Correspondent
KCI USA, INC.
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Correspondent Contact MARGARET MARSH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/02/2015
Decision Date 02/29/2016
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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