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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 K121883
Device Name PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
Applicant
Kci USA, Inc. (Kinetic Concepts, Inc.)
6203 Farinon Dr.
San Antonio,  TX  78249
Applicant Contact Shannon Scott
Correspondent
Kci USA, Inc. (Kinetic Concepts, Inc.)
6203 Farinon Dr.
San Antonio,  TX  78249
Correspondent Contact Shannon Scott
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/28/2012
Decision Date 10/11/2012
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
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