FDA 510(k)

Disposable Surgical Face Mask

Número K: K202491 · 2021-01-06

RequerenteJiangsu Newvalue Medical Products Co., Ltd.

Data da decisão2021-01-06

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Newvalue Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K202491. 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 Surgical Face Mask?

Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Jiangsu Newvalue Medical Products Co., Ltd.. The 510(k) number is K202491.

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

Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-01-06, under 510(k) number K202491.

Who is the listed applicant for Disposable Surgical Face Mask?

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

What is the FDA product code for Disposable Surgical Face Mask?

The FDA product code for Disposable Surgical Face Mask is FXX.

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