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FDA 510(k), K200918, SurgiWrap FROST
FDA 510(k), K200918, SurgiWrap FROST
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510(K) Number: K200918
Device Name: SurgiWrap FROST
Manufacturer: Roel Trip
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: 04/06/2020
Date Received: 01/07/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SurgiWrap FROST
Manufacturer: Roel Trip
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: 04/06/2020
Date Received: 01/07/2021
Decision Date: Substantially Equivalent (SESE)
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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