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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 K063692
Device Name V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
Applicant
KCI USA, INC.
8023 vantage dr.
san antonio,  TX  78230 -4726
Applicant Contact margaret marsh
Correspondent
KCI USA, INC.
8023 vantage dr.
san antonio,  TX  78230 -4726
Correspodent Contact margaret marsh
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/13/2006
Decision Date 06/07/2007
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
Recalls CDRH Recalls
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