FDA 510(k)

Surgical Masks, Model:FE-1

Número K: K210767 · 2021-06-10

RequerenteHunan Triplex Precision Medical Devices Co., Ltd.

Data da decisão2021-06-10

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Masks, Model:FE-1 is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Triplex Precision Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2021-06-10 under 510(k) number K210767. 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 Masks, Model:FE-1?

Surgical Masks, Model:FE-1 is a medical device that received FDA 510(k) clearance on 2021-06-10. The listed applicant is Hunan Triplex Precision Medical Devices Co., Ltd.. The 510(k) number is K210767.

When did Surgical Masks, Model:FE-1 receive FDA 510(k) clearance?

Surgical Masks, Model:FE-1 received FDA 510(k) clearance on 2021-06-10, under 510(k) number K210767.

Who is the listed applicant for Surgical Masks, Model:FE-1?

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

What is the FDA product code for Surgical Masks, Model:FE-1?

The FDA product code for Surgical Masks, Model:FE-1 is FXX.

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