FDA 510(k)

Surgical Gown

N.º K: K213844 · 2023-02-16

SolicitanteBayteks Teknik Tekstil San. VE Tic. A.S.

Fecha de decisión2023-02-16

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 Bayteks Teknik Tekstil San. VE Tic. A.S.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K213844. 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 2023-02-16. The listed applicant is Bayteks Teknik Tekstil San. VE Tic. A.S.. The 510(k) number is K213844.

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

Surgical Gown received FDA 510(k) clearance on 2023-02-16, under 510(k) number K213844.

Who is the listed applicant for Surgical Gown?

The FDA 510(k) record lists Bayteks Teknik Tekstil San. VE Tic. A.S. 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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