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FDA 510(k), K151852, PacEndo Sodium Hyprochlorite
FDA 510(k), K151852, PacEndo Sodium Hyprochlorite
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510(K) Number: K151852
Device Name: PacEndo Sodium Hyprochlorite
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Cleanser, Root Canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 07/07/2015
Decision Date: 11/10/2015
Regulation Medical Specialty:
Device Name: PacEndo Sodium Hyprochlorite
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Cleanser, Root Canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 07/07/2015
Decision Date: 11/10/2015
Regulation Medical Specialty:
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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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