FDA 510(k)

Disposable Medical Mask

Número K: K202655 · 2021-04-05

RequerenteDongguan Runlin Medical Supplies Technology Co., Ltd.

Data da decisão2021-04-05

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 Dongguan Runlin Medical Supplies Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-04-05 under 510(k) number K202655. 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 2021-04-05. The listed applicant is Dongguan Runlin Medical Supplies Technology Co., Ltd.. The 510(k) number is K202655.

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

Disposable Medical Mask received FDA 510(k) clearance on 2021-04-05, under 510(k) number K202655.

Who is the listed applicant for Disposable Medical Mask?

The FDA 510(k) record lists Dongguan Runlin Medical Supplies Technology 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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