FDA 510(k)

Medical surgical mask

Número K: K201622 · 2020-11-24

RequerenteGuangdong Kingfa Sci. & Tech.Co., Ltd.

Data da decisão2020-11-24

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical surgical mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K201622. 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 Medical surgical mask?

Medical surgical mask is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K201622.

When did Medical surgical mask receive FDA 510(k) clearance?

Medical surgical mask received FDA 510(k) clearance on 2020-11-24, under 510(k) number K201622.

Who is the listed applicant for Medical surgical mask?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical surgical mask?

The FDA product code for Medical surgical mask is FXX.

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Outros registros que listam Guangdong Kingfa Sci. & Tech.Co., Ltd. como candidato(a)

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Fonte oficial

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