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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 K032310
Device Name MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
Applicant
KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO,  TX  78216 -9508
Applicant Contact JUDITH HARBOUR
Correspondent
KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO,  TX  78216 -9508
Correspondent Contact JUDITH HARBOUR
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/28/2003
Decision Date 10/10/2003
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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