FDA 510(k)

Disposable Medical Mask

Número K: K203112 · 2021-09-16

RequerenteYangzhou Runyi Arts & Crafts Co., Ltd.

Data da decisão2021-09-16

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Runyi Arts & Crafts Co., Ltd.. It received FDA 510(k) clearance on 2021-09-16 under 510(k) number K203112. 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 Disposable Medical Mask?

Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Yangzhou Runyi Arts & Crafts Co., Ltd.. The 510(k) number is K203112.

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

Disposable Medical Mask received FDA 510(k) clearance on 2021-09-16, under 510(k) number K203112.

Who is the listed applicant for Disposable Medical Mask?

The FDA 510(k) record lists Yangzhou Runyi Arts & Crafts Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Mask?

The FDA product code for Disposable Medical Mask is FXX.

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