FDA 510(k), K223263, Prevena Plus 125 Therapy Unit

FDA 510(k), K223263, Prevena Plus 125 Therapy Unit

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
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: KXA
Date Received: 10/24/2022
Decision Date: 02/13/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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.

View full details