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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 K063426
Device Name V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
Applicant
Kci USA, Inc.
8023 Vantage Dr.
San Antonio,  TX  78230
Applicant Contact VERONIQUE SMITH
Correspondent
Kci USA, Inc.
8023 Vantage Dr.
San Antonio,  TX  78230
Correspondent Contact VERONIQUE SMITH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/13/2006
Decision Date 12/13/2006
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
Predetermined Change
Control Plan Authorized		 No
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