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FDA 510(k), K180631, Silk Voice
FDA 510(k), K180631, Silk Voice
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510(K) Number: K180631
Device Name: Silk Voice
Manufacturer: Anh Hoang
Device Classification Name: System, Vocal Cord Medialization
Regulation Number: MIX
Classification Product Code: 03/09/2018
Date Received: 11/08/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Silk Voice
Manufacturer: Anh Hoang
Device Classification Name: System, Vocal Cord Medialization
Regulation Number: MIX
Classification Product Code: 03/09/2018
Date Received: 11/08/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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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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