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FDA 510(k), K161897, PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
FDA 510(k), K161897, PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
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510(K) Number: K161897
Device Name: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
Manufacturer: KCI USA, INC. (KINETIC CONCEPTS, INC.)
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 07/11/2016
Decision Date: 10/04/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
Manufacturer: KCI USA, INC. (KINETIC CONCEPTS, INC.)
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 07/11/2016
Decision Date: 10/04/2016
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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