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FDA 510(k), K172452, Bruxor
FDA 510(k), K172452, Bruxor
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510(K) Number: K172452
Device Name: Bruxor
Manufacturer: Sleep Specialties, LLC
Device Classification Name: Mouthguard, Over-The-Counter
Regulation Number:
Classification Product Code: OBR
Date Received: 08/14/2017
Decision Date: 01/11/2018
Regulation Medical Specialty:
Device Name: Bruxor
Manufacturer: Sleep Specialties, LLC
Device Classification Name: Mouthguard, Over-The-Counter
Regulation Number:
Classification Product Code: OBR
Date Received: 08/14/2017
Decision Date: 01/11/2018
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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