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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 K053627
Device Name MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
Applicant
KCI USA, INC.
8023 VANTAGE DR.
SAN ANTONIO,  TX  78230 -4726
Applicant Contact CHRISTY H OVIATT
Correspondent
KCI USA, INC.
8023 VANTAGE DR.
SAN ANTONIO,  TX  78230 -4726
Correspondent Contact CHRISTY H OVIATT
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/29/2005
Decision Date 02/06/2006
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 Yes
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