FDA 510(k)

Disposable Face Mask

Número K: K210815 · 2021-05-13

RequerenteBiobase Scientific (Shandong) Co., Ltd.

Data da decisão2021-05-13

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Biobase Scientific (Shandong) Co., Ltd.. It received FDA 510(k) clearance on 2021-05-13 under 510(k) number K210815. 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 Face Mask?

Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is Biobase Scientific (Shandong) Co., Ltd.. The 510(k) number is K210815.

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

Disposable Face Mask received FDA 510(k) clearance on 2021-05-13, under 510(k) number K210815.

Who is the listed applicant for Disposable Face Mask?

The FDA 510(k) record lists Biobase Scientific (Shandong) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Face Mask?

The FDA product code for Disposable Face Mask is FXX.

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