FDA 510(k)

Medical Face Mask

Número K: K211363 · 2021-07-24

RequerenteHubei Kangning Protective Products Co., Ltd.

Data da decisão2021-07-24

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Kangning Protective Products Co., Ltd.. It received FDA 510(k) clearance on 2021-07-24 under 510(k) number K211363. 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 Face Mask?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-24. The listed applicant is Hubei Kangning Protective Products Co., Ltd.. The 510(k) number is K211363.

When did Medical Face Mask receive FDA 510(k) clearance?

Medical Face Mask received FDA 510(k) clearance on 2021-07-24, under 510(k) number K211363.

Who is the listed applicant for Medical Face Mask?

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

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

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