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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 K120499
Device Name ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
Original Applicant
KCI USA, INC. (KINETIC CONCEPTS, INC.)
6203 farinon drive
san antonio,  TX  78249
Original Contact margaret marsh
Regulation Number878.4780
Classification Product Code
OMP  
Date Received02/21/2012
Decision Date 10/05/2012
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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