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FDA 510(k), K123866, TANYX
FDA 510(k), K123866, TANYX
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510(K) Number: K123866
Device Name: TANYX
Manufacturer: MEDECELL US, INC
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 12/17/2012
Decision Date: 09/13/2013
Regulation Medical Specialty: Neurology
Device Name: TANYX
Manufacturer: MEDECELL US, INC
Device Classification Name: stimulator, nerve, transcutaneous, over-the-counter
Regulation Number: 882.5890
Classification Product Code: NUH
Date Received: 12/17/2012
Decision Date: 09/13/2013
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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