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FDA 510(k), K151399, Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
FDA 510(k), K151399, Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
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$149.00 USD
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510(K) Number: K151399
Device Name: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
Manufacturer: ANTJE MAURER
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: EBF
Classification Product Code: 05/26/2015
Date Received: 10/24/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
Manufacturer: ANTJE MAURER
Device Classification Name: Material, Tooth Shade, Resin
Regulation Number: EBF
Classification Product Code: 05/26/2015
Date Received: 10/24/2016
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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