FDA 510(k)

GD Disposable Medical Face Mask

Número K: K201718 · 2021-04-15

RequerenteJiangsu Guangda Medical Material Group Co., Ltd.

Data da decisão2021-04-15

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GD Disposable Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Guangda Medical Material Group Co., Ltd.. It received FDA 510(k) clearance on 2021-04-15 under 510(k) number K201718. 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 GD Disposable Medical Face Mask?

GD Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-04-15. The listed applicant is Jiangsu Guangda Medical Material Group Co., Ltd.. The 510(k) number is K201718.

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

GD Disposable Medical Face Mask received FDA 510(k) clearance on 2021-04-15, under 510(k) number K201718.

Who is the listed applicant for GD Disposable Medical Face Mask?

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

What is the FDA product code for GD Disposable Medical Face Mask?

The FDA product code for GD Disposable Medical Face Mask is FXX.

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