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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 K091585
Device Name VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
Applicant
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Applicant Contact MARGARET MARSH
Correspondent
KCI USA, INC.
6203 FARINON DR.
SAN ANTONIO,  TX  78249
Correspondent Contact MARGARET MARSH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/02/2009
Decision Date 12/29/2009
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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