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FDA 510(k), K191033, LunaGuard Nighttime Dental Protector
FDA 510(k), K191033, LunaGuard Nighttime Dental Protector
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$149.00 USD
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$149.00 USD
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510(K) Number: K191033
Device Name: LunaGuard Nighttime Dental Protector
Manufacturer: McKeon Products
Device Classification Name: Mouthguard, Over-The-Counter
Regulation Number:
Classification Product Code: OBR
Date Received: 04/18/2019
Decision Date: 08/05/2019
Regulation Medical Specialty:
Device Name: LunaGuard Nighttime Dental Protector
Manufacturer: McKeon Products
Device Classification Name: Mouthguard, Over-The-Counter
Regulation Number:
Classification Product Code: OBR
Date Received: 04/18/2019
Decision Date: 08/05/2019
Regulation Medical Specialty:
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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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