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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 K083357
Device Name OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
Applicant
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Applicant Contact CHRISTY H OVIATT
Correspondent
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Correspondent Contact CHRISTY H OVIATT
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/13/2008
Decision Date 03/04/2009
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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