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FDA 510(k), K132109, ENAMELAST
FDA 510(k), K132109, ENAMELAST
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510(K) Number: K132109
Device Name: ENAMELAST
Manufacturer: KAREN KAKUNES
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: 07/08/2013
Date Received: 11/01/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: ENAMELAST
Manufacturer: KAREN KAKUNES
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: 07/08/2013
Date Received: 11/01/2013
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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