FDA 510(k), K152684, Nerve Capping Device
FDA 510(k), K152684, Nerve Capping Device
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510(K) Number: K152684
Device Name: Nerve Capping Device
Manufacturer: POLYGANICS INNOVATIONS BV
Device Classification Name: cuff, nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 09/18/2015
Decision Date: 01/13/2016
Regulation Medical Specialty: Neurology
Device Name: Nerve Capping Device
Manufacturer: POLYGANICS INNOVATIONS BV
Device Classification Name: cuff, nerve
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 09/18/2015
Decision Date: 01/13/2016
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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