FDA 510(k)

Surgical Isolation Gown

N.º K: K203415 · 2021-05-20

SolicitanteYanbian Pacific Textile Co., Ltd.

Fecha de decisión2021-05-20

Código de productoFYC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Yanbian Pacific Textile Co., Ltd.. It received FDA 510(k) clearance on 2021-05-20 under 510(k) number K203415. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Surgical Isolation Gown?

Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-05-20. The listed applicant is Yanbian Pacific Textile Co., Ltd.. The 510(k) number is K203415.

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

Surgical Isolation Gown received FDA 510(k) clearance on 2021-05-20, under 510(k) number K203415.

Who is the listed applicant for Surgical Isolation Gown?

The FDA 510(k) record lists Yanbian Pacific Textile Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Isolation Gown?

The FDA product code for Surgical Isolation Gown is FYC.

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Fuente oficial

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