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FDA 510(k), K972375, IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
FDA 510(k), K972375, IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
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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: 06/25/1997
Date Received: 09/10/1997
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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: 06/25/1997
Date Received: 09/10/1997
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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