FDA 510(k), K220660, Prevena Restor Adapti-Form Dressing
FDA 510(k), K220660, Prevena Restor Adapti-Form Dressing
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$149.00 USD
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510(K) Number: K220660
Device Name: Prevena Restor Adapti-Form Dressing
Manufacturer: Teri Feeley
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: 03/07/2022
Date Received: 07/01/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Prevena Restor Adapti-Form Dressing
Manufacturer: Teri Feeley
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: 03/07/2022
Date Received: 07/01/2022
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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