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FDA 510(k), K201238, Encore System
FDA 510(k), K201238, Encore System
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510(K) Number: K201238
Device Name: Encore System
Manufacturer: Michael Kolber
Device Classification Name: Tongue Suspension System
Regulation Number: ORY
Classification Product Code: 05/07/2020
Date Received: 10/02/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Encore System
Manufacturer: Michael Kolber
Device Classification Name: Tongue Suspension System
Regulation Number: ORY
Classification Product Code: 05/07/2020
Date Received: 10/02/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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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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