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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 K181507
Device Name PREVENA RESTOR(TM) Incision Management System
Applicant
KCI USA, Inc.
6203 Farinon Drive
san antonio,  TX  78249
Applicant Contact kimberly mccoy
Correspondent
KCI USA, Inc.
6203 Farinon Drive
san antonio,  TX  78249
Correspondent Contact shannon scott
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/07/2018
Decision Date 02/15/2019
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 Yes
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