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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 K183543
Device Name ACTIV.A.C. Therapy Unit
Applicant
Kci Usa, Inc.
6203 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact Teri Feeley
Correspondent
Kci Usa, Inc.
6203 Farinon Dr.
San Antonio,  TX  78249
Correspondent Contact Teri Feeley
Regulation Number878.4780
Classification Product Code
OMP  
Date Received12/20/2018
Decision Date 03/20/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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