FDA 510(k)

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

Número K: K151399 · 2016-10-24

Data da decisão2016-10-24

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow is the device name listed in this FDA 510(k) record. The listed applicant is Schutz Dental GmbH. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K151399. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow?

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Schutz Dental GmbH. The 510(k) number is K151399.

When did Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow receive FDA 510(k) clearance?

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow received FDA 510(k) clearance on 2016-10-24, under 510(k) number K151399.

Who is the listed applicant for Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow?

The FDA 510(k) record lists Schutz Dental GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow?

The FDA product code for Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow is EBF.

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