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FDA 510(k), K151150, Elements
FDA 510(k), K151150, Elements
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510(K) Number: K151150
Device Name: Elements
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Material, Impression
Regulation Number: 872.3660
Classification Product Code: ELW
Date Received: 04/30/2015
Decision Date: 07/28/2015
Regulation Medical Specialty: Dental
Device Name: Elements
Manufacturer: PAC-DENT INTERNATIONAL, INC.
Device Classification Name: Material, Impression
Regulation Number: 872.3660
Classification Product Code: ELW
Date Received: 04/30/2015
Decision Date: 07/28/2015
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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