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510(k) Premarket Notification

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Device Classification Name negative pressure wound therapy powered suction pump
510(k) NumberK021500
Device NameVACUUM ASSISTED CLOSURE
Applicant
KINETIC CONCEPTS, INC.
p.o. box 659508
san antonio,  TX  78265 950
Contactwilliam h quirk
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/09/2002
Decision Date 12/20/2002
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary/purged 510(k)
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
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