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FDA 510(k), K161715, EndyGel
FDA 510(k), K161715, EndyGel
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510(K) Number: K161715
Device Name: EndyGel
Manufacturer: EndyMed Medical Ltd.
Device Classification Name: media, electroconductive
Regulation Number: 882.1275
Classification Product Code: GYB
Date Received: 06/21/2016
Decision Date: 02/07/2017
Regulation Medical Specialty: Neurology
Device Name: EndyGel
Manufacturer: EndyMed Medical Ltd.
Device Classification Name: media, electroconductive
Regulation Number: 882.1275
Classification Product Code: GYB
Date Received: 06/21/2016
Decision Date: 02/07/2017
Regulation Medical Specialty: Neurology
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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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