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FDA 510(k)

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

Número K: K212293 · 2021-10-25

RequerenteJiangmen Ningrui Medical Supplies Co., Ltd.
Data da decisão2021-10-25
Código do produtoFXX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangmen Ningrui Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-10-25 under 510(k) number K212293. 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 Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)?

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) is a medical device that received FDA 510(k) clearance on 2021-10-25. The listed applicant is Jiangmen Ningrui Medical Supplies Co., Ltd.. The 510(k) number is K212293.

When did Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) receive FDA 510(k) clearance?

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) received FDA 510(k) clearance on 2021-10-25, under 510(k) number K212293.

Who is the listed applicant for Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)?

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

What is the FDA product code for Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)?

The FDA product code for Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) is FXX.

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Dispositivos Relacionados (Código: FXX)

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Fonte oficial

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