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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 K063740
Device Name V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
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
Correspondent Contact MARGARET MARSH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/18/2006
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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