FDA 510(k)

Disposable Surgical Gowns

N.º K: K210785 · 2021-11-13

SolicitanteChongqing Litai Fashion Group Limited Company

Fecha de decisión2021-11-13

Código de productoFYC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Surgical Gowns is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Litai Fashion Group Limited Company. It received FDA 510(k) clearance on 2021-11-13 under 510(k) number K210785. 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 Disposable Surgical Gowns?

Disposable Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-11-13. The listed applicant is Chongqing Litai Fashion Group Limited Company. The 510(k) number is K210785.

When did Disposable Surgical Gowns receive FDA 510(k) clearance?

Disposable Surgical Gowns received FDA 510(k) clearance on 2021-11-13, under 510(k) number K210785.

Who is the listed applicant for Disposable Surgical Gowns?

The FDA 510(k) record lists Chongqing Litai Fashion Group Limited Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gowns?

The FDA product code for Disposable Surgical Gowns is FYC.

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Fuente oficial

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