FDA 510(k)

Surgical face mask

Número K: K211296 · 2021-09-11

RequerenteSunsmed Protective Products , Ltd.

Data da decisão2021-09-11

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical face mask is the device name listed in this FDA 510(k) record. The listed applicant is Sunsmed Protective Products , Ltd.. It received FDA 510(k) clearance on 2021-09-11 under 510(k) number K211296. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surgical face mask?

Surgical face mask is a medical device that received FDA 510(k) clearance on 2021-09-11. The listed applicant is Sunsmed Protective Products , Ltd.. The 510(k) number is K211296.

When did Surgical face mask receive FDA 510(k) clearance?

Surgical face mask received FDA 510(k) clearance on 2021-09-11, under 510(k) number K211296.

Who is the listed applicant for Surgical face mask?

The FDA 510(k) record lists Sunsmed Protective Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical face mask?

The FDA product code for Surgical face mask is FXX.

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