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FDA 510(k), K212519, Overjet Caries Assist
FDA 510(k), K212519, Overjet Caries Assist
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$149.00 USD
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510(K) Number: K212519
Device Name: Overjet Caries Assist
Manufacturer: Wardah Inam
Device Classification Name: Analyzer, Medical Image
Regulation Number: MYN
Classification Product Code: 08/10/2021
Date Received: 05/10/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Overjet Caries Assist
Manufacturer: Wardah Inam
Device Classification Name: Analyzer, Medical Image
Regulation Number: MYN
Classification Product Code: 08/10/2021
Date Received: 05/10/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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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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