FDA 510(k)

Maxima Surgical Gown

N.º K: K201351 · 2022-03-11

Fecha de decisión2022-03-11

Código de productoFYA

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Maxima Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Elevate Textiles. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K201351. 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 Maxima Surgical Gown?

Maxima Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Elevate Textiles. The 510(k) number is K201351.

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

Maxima Surgical Gown received FDA 510(k) clearance on 2022-03-11, under 510(k) number K201351.

Who is the listed applicant for Maxima Surgical Gown?

The FDA 510(k) record lists Elevate Textiles as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maxima Surgical Gown?

The FDA product code for Maxima Surgical Gown is FYA.

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Fuente oficial

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