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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 K100821
FOIA Releasable 510(k) K100821
Device Name PREVENA INCISION MANAGEMENT SYSTEM
Applicant
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Applicant Contact MARGARET MARSH
Correspondent
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Correspondent Contact MARGARET MARSH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received03/23/2010
Decision Date 06/11/2010
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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