FDA 510(k)

ClearMet

Número K: K152051 · 2016-03-22

RequerenteMycone Dental Supply Co., T/A Keystone Industries

Data da decisão2016-03-22

Código do produtoEBI

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

ClearMet is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Co., T/A Keystone Industries. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K152051. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClearMet?

ClearMet is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is Mycone Dental Supply Co., T/A Keystone Industries. The 510(k) number is K152051.

When did ClearMet receive FDA 510(k) clearance?

ClearMet received FDA 510(k) clearance on 2016-03-22, under 510(k) number K152051.

Who is the listed applicant for ClearMet?

The FDA 510(k) record lists Mycone Dental Supply Co., T/A Keystone Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearMet?

The FDA product code for ClearMet is EBI.

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Fonte oficial

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