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FDA 510(k), K182917, FluoroCal
FDA 510(k), K182917, FluoroCal
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510(K) Number: K182917
Device Name: FluoroCal
Manufacturer: Ryan Hobson
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: KXA
Date Received: 10/19/2018
Decision Date: 11/18/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: FluoroCal
Manufacturer: Ryan Hobson
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: KXA
Date Received: 10/19/2018
Decision Date: 11/18/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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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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