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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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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: KXA
Date Received: 05/26/2015
Decision Date: 10/24/2016
Decision: 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: KXA
Date Received: 05/26/2015
Decision Date: 10/24/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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