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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 K201571
Device Name ACTIV.A.C. Negative Pressure Wound Therapy System
Applicant
KCI USA, Inc
6203 Farinon Drive
San Antonio,  TX  78249
Applicant Contact Jesus Valencia
Correspondent
KCI USA, Inc
6203 Farinon Drive
San Antonio,  TX  78249
Correspondent Contact Jesus Valencia
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/11/2020
Decision Date 07/08/2020
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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