FDA 510(k)

Surgical Face Mask

Número K: K202277 · 2020-09-25

RequerenteJiangxi 3l Medical Products Group Co., Ltd.

Data da decisão2020-09-25

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi 3l Medical Products Group Co., Ltd.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K202277. 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 Surgical Face Mask?

Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Jiangxi 3l Medical Products Group Co., Ltd.. The 510(k) number is K202277.

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

Surgical Face Mask received FDA 510(k) clearance on 2020-09-25, under 510(k) number K202277.

Who is the listed applicant for Surgical Face Mask?

The FDA 510(k) record lists Jiangxi 3l Medical Products Group Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Face Mask?

The FDA product code for Surgical Face Mask is FXX.

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