FDA 510(k), K223263, Prevena Plus 125 Therapy Unit
FDA 510(k), K223263, Prevena Plus 125 Therapy Unit
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510(K) Number: K223263
Device Name: Prevena Plus 125 Therapy Unit
Manufacturer: Teri Feeley
Device Classification Name: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Regulation Number: QFC
Classification Product Code: 10/24/2022
Date Received: 02/13/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Prevena Plus 125 Therapy Unit
Manufacturer: Teri Feeley
Device Classification Name: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Regulation Number: QFC
Classification Product Code: 10/24/2022
Date Received: 02/13/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
- 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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