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FDA 510(k), K151580, D.N.E. External Fixation System
FDA 510(k), K151580, D.N.E. External Fixation System
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$149.00 USD
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510(K) Number: K151580
Device Name: D.N.E. External Fixation System
Manufacturer: NICHOLAS RICCIONE
Device Classification Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation Number: KTT
Classification Product Code: 06/11/2015
Date Received: 02/16/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: D.N.E. External Fixation System
Manufacturer: NICHOLAS RICCIONE
Device Classification Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation Number: KTT
Classification Product Code: 06/11/2015
Date Received: 02/16/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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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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