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FDA 510(k), K173426, PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
FDA 510(k), K173426, PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
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510(K) Number: K173426
Device Name: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
Manufacturer: KCI USA, INC.
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 11/02/2017
Decision Date: 03/09/2018
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
Manufacturer: KCI USA, INC.
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 11/02/2017
Decision Date: 03/09/2018
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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