FDA 510(k)

Surgical Face Masks

Número K: K202708 · 2021-03-30

Data da decisão2021-03-30

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Intco Medical(Hk) Co., Ltd.. It received FDA 510(k) clearance on 2021-03-30 under 510(k) number K202708. 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 Masks?

Surgical Face Masks is a medical device that received FDA 510(k) clearance on 2021-03-30. The listed applicant is Intco Medical(Hk) Co., Ltd.. The 510(k) number is K202708.

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

Surgical Face Masks received FDA 510(k) clearance on 2021-03-30, under 510(k) number K202708.

Who is the listed applicant for Surgical Face Masks?

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

What is the FDA product code for Surgical Face Masks?

The FDA product code for Surgical Face Masks is FXX.

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