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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 K133276
Device Name V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
Applicant
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Applicant Contact MELANIE AVILA
Correspondent
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Correspondent Contact MELANIE AVILA
Regulation Number878.4780
Classification Product Code
OMP  
Date Received10/24/2013
Decision Date 11/19/2013
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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