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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 K173426
Device Name PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
Applicant
Kci USA, Inc.
6203 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact Margaret Marsh
Correspondent
Kci USA, Inc.
6203 Farinon Dr.
San Antonio,  TX  78249
Correspondent Contact Margaret Marsh
Regulation Number878.4780
Classification Product Code
OMP  
Date Received11/02/2017
Decision Date 03/09/2018
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 Yes
Predetermined Change
Control Plan Authorized		 No
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