FDA 510(k) K180855, Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, by Kci USA, Inc.
FDA 510(k) K180855, Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, by Kci USA, Inc.
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number: K180855
Device Name: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
Applicant: Kci USA, Inc.
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 04/02/2018
Decision Date: 06/01/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery
Total number of pages: 1,567
Fully redacted pages: 1,422
Content pages: 145
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