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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 K120033
Models 320000, 340000, 340097, 60300, M8259968, M8259999, ULTDEV01/US
Device Name ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
Original Applicant
KCI USA, INC.
6203 farinon dr.
san antonio,  TX  78249
Original Contact shannon scott
Regulation Number878.4780
Classification Product Code
OMP  
Date Received01/04/2012
Decision Date 05/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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