FDA 510(k)

Disposable Ultra Reinforced Surgical Gown

Número K: K173847 · 2019-01-16

RequerenteXiantao Rayxin Medical Products Co., Ltd.

Data da decisão2019-01-16

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Ultra Reinforced Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Rayxin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) number K173847. 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 Disposable Ultra Reinforced Surgical Gown?

Disposable Ultra Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2019-01-16. The listed applicant is Xiantao Rayxin Medical Products Co., Ltd.. The 510(k) number is K173847.

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

Disposable Ultra Reinforced Surgical Gown received FDA 510(k) clearance on 2019-01-16, under 510(k) number K173847.

Who is the listed applicant for Disposable Ultra Reinforced Surgical Gown?

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

What is the FDA product code for Disposable Ultra Reinforced Surgical Gown?

The FDA product code for Disposable Ultra Reinforced Surgical Gown is FYA.

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Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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