FDA 510(k)

Surgical Gown

Número K: K212812 · 2022-11-16

RequerenteXianning Marveldas Protective Articles Co., Ltd.

Data da decisão2022-11-16

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Xianning Marveldas Protective Articles Co., Ltd.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K212812. 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?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Xianning Marveldas Protective Articles Co., Ltd.. The 510(k) number is K212812.

When did Surgical Gown receive FDA 510(k) clearance?

Surgical Gown received FDA 510(k) clearance on 2022-11-16, under 510(k) number K212812.

Who is the listed applicant for Surgical Gown?

The FDA 510(k) record lists Xianning Marveldas Protective Articles Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown?

The FDA product code for Surgical Gown is FYA.

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Fonte oficial

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