FDA 510(k)

Surgical Gown

N.º K: K192560 · 2020-05-22

SolicitanteShandong Kangli Medical Equipment Technology Co., Ltd.

Fecha de decisión2020-05-22

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Kangli Medical Equipment Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K192560. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Surgical Gown?

Surgical Gown is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is Shandong Kangli Medical Equipment Technology Co., Ltd.. The 510(k) number is K192560.

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

Surgical Gown received FDA 510(k) clearance on 2020-05-22, under 510(k) number K192560.

Who is the listed applicant for Surgical Gown?

The FDA 510(k) record lists Shandong Kangli Medical Equipment Technology 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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Dispositivos relacionados (Código: FYA)

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Fuente oficial

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