FDA 510(k), K153528, PacEndo EDTA
FDA 510(k), K153528, PacEndo EDTA
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510(K) Number: K153528
Device Name: PacEndo EDTA
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Cleanser, Root Canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 12/09/2015
Decision Date: 02/01/2016
Regulation Medical Specialty:
Device Name: PacEndo EDTA
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Cleanser, Root Canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 12/09/2015
Decision Date: 02/01/2016
Regulation Medical Specialty:
- 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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