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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 K123507
Device Name KCI NPWT GAUZE DRESSING
Applicant
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Applicant Contact ANONA GOEBEL
Correspondent
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Correspondent Contact ANONA GOEBEL
Regulation Number878.4780
Classification Product Code
OMP  
Subsequent Product Code
FRO  
Date Received11/13/2012
Decision Date 04/04/2013
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 Yes
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