FDA 510(k)

Medline Orbis Surgical Gown

N.º K: K202447 · 2021-04-02

Fecha de decisión2021-04-02

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medline Orbis Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K202447. 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 Medline Orbis Surgical Gown?

Medline Orbis Surgical Gown is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Medline Industries, Inc.. The 510(k) number is K202447.

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

Medline Orbis Surgical Gown received FDA 510(k) clearance on 2021-04-02, under 510(k) number K202447.

Who is the listed applicant for Medline Orbis Surgical Gown?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Orbis Surgical Gown?

The FDA product code for Medline Orbis Surgical Gown is FYA.

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Dispositivos relacionados (Código: FYA)

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Fuente oficial

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