FDA 510(k)

Surgical Gown, Model: surgical gown-hp-3

Número K: K210355 · 2021-12-16

RequerenteWeihai Dishang Medical Technology Co., Ltd.

Data da decisão2021-12-16

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Gown, Model: surgical gown-hp-3 is the device name listed in this FDA 510(k) record. The listed applicant is Weihai Dishang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K210355. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surgical Gown, Model: surgical gown-hp-3?

Surgical Gown, Model: surgical gown-hp-3 is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Weihai Dishang Medical Technology Co., Ltd.. The 510(k) number is K210355.

When did Surgical Gown, Model: surgical gown-hp-3 receive FDA 510(k) clearance?

Surgical Gown, Model: surgical gown-hp-3 received FDA 510(k) clearance on 2021-12-16, under 510(k) number K210355.

Who is the listed applicant for Surgical Gown, Model: surgical gown-hp-3?

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

What is the FDA product code for Surgical Gown, Model: surgical gown-hp-3?

The FDA product code for Surgical Gown, Model: surgical gown-hp-3 is FYA.

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Outros registros que listam Weihai Dishang Medical Technology Co., Ltd. como candidato(a)

K210348Disposable Medical Surgical Mask

Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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