1
/
of
0
FDA 510(k), K132109, ENAMELAST
FDA 510(k), K132109, ENAMELAST
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
510(K) Number: K132109
Device Name: ENAMELAST
Manufacturer: KAREN KAKUNES
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: KXA
Date Received: 07/08/2013
Decision Date: 11/01/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: ENAMELAST
Manufacturer: KAREN KAKUNES
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: KXA
Date Received: 07/08/2013
Decision Date: 11/01/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Couldn't load pickup availability
- 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.
View full details