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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 K093526
Device Name V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D
Applicant
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Applicant Contact RANDALL WHEELAND
Correspondent
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 FARINON DRIVE
SAN ANTONIO,  TX  78249
Correspondent Contact RANDALL WHEELAND
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/16/2009
Decision Date 03/10/2010
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
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