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FDA 510(k)

Banyan USA Surgical Mask Level 3

N.º K: K211097 · 2021-09-22

SolicitanteBanyan USA, LLC
Fecha de decisión2021-09-22
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Banyan USA Surgical Mask Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Banyan USA, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K211097. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Banyan USA Surgical Mask Level 3?

Banyan USA Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Banyan USA, LLC. The 510(k) number is K211097.

When did Banyan USA Surgical Mask Level 3 receive FDA 510(k) clearance?

Banyan USA Surgical Mask Level 3 received FDA 510(k) clearance on 2021-09-22, under 510(k) number K211097.

Who is the listed applicant for Banyan USA Surgical Mask Level 3?

The FDA 510(k) record lists Banyan USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Banyan USA Surgical Mask Level 3?

The FDA product code for Banyan USA Surgical Mask Level 3 is FXX.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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