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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 K063590
Device Name V.A.C. FREEDOM CANISTER, MODEL M6275421; V.A.C. ATS CANISTER, MODELS K6275422, M6275423
Applicant
KCI USA, INC.
8023 VANTAGE DR.
SAN ANTONIO,  TX  78230 -4726
Applicant Contact CHRISTY HUBBARD OVIATT
Correspondent
KCI USA, INC.
8023 VANTAGE DR.
SAN ANTONIO,  TX  78230 -4726
Correspondent Contact CHRISTY HUBBARD OVIATT
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/01/2006
Decision Date 01/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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