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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 K111280
Device Name V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
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 Received05/06/2011
Decision Date 07/21/2011
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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