FDA 510(k), K972375, IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE

FDA 510(k), K972375, IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE

Regular price $49.00 USD
Regular price Sale price $49.00 USD
Sale Sold out
510(K) Number: K972375
Device Name: IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
Manufacturer: JOHN I GRUEN
Device Classification Name: Handpiece, Air-Powered, Dental
Regulation Number: EFB
Classification Product Code: KXA
Date Received: 06/25/1997
Decision Date: 09/10/1997
Decision: Substantially Equivalent (SESE)
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.

View full details