FDA 510(k), K945794, DURAPHAT

FDA 510(k), K945794, DURAPHAT

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510(K) Number: K945794
Device Name: DURAPHAT
Manufacturer: INPHARMA
Device Classification Name: Varnish, Cavity
Regulation Number: 872.3260
Classification Product Code: LBH
Date Received: 11/25/1994
Decision Date: 07/26/1995
Regulation Medical Specialty: Dental
  • 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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