FDA 510(k), K201631, VersaWrap Nerve Protector
FDA 510(k), K201631, VersaWrap Nerve Protector
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510(K) Number: K201631
Device Name: VersaWrap Nerve Protector
Manufacturer: Alafair Biosciences Inc
Device Classification Name: cuff, nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 06/16/2020
Decision Date: 09/14/2020
Regulation Medical Specialty: Neurology
Device Name: VersaWrap Nerve Protector
Manufacturer: Alafair Biosciences Inc
Device Classification Name: cuff, nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 06/16/2020
Decision Date: 09/14/2020
Regulation Medical Specialty: Neurology
- 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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