FDA 510(k)

Charisma

Número K: K160049 · 2016-11-15

RequerenteHeraeus Kulzer, LLC (Mitsui Chemicals Group)

Data da decisão2016-11-15

Código do produtoEBF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Charisma is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC (Mitsui Chemicals Group). It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K160049. 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 Charisma?

Charisma is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Heraeus Kulzer, LLC (Mitsui Chemicals Group). The 510(k) number is K160049.

When did Charisma receive FDA 510(k) clearance?

Charisma received FDA 510(k) clearance on 2016-11-15, under 510(k) number K160049.

Who is the listed applicant for Charisma?

The FDA 510(k) record lists Heraeus Kulzer, LLC (Mitsui Chemicals Group) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Charisma?

The FDA product code for Charisma is EBF.

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Fonte oficial

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