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FDA 510(k)

Medical surgical mask

N.º K: K210380 · 2021-07-08

SolicitanteShantou T&K Medical Equipment Factory Co.,Ltd
Fecha de decisión2021-07-08
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical surgical mask is the device name listed in this FDA 510(k) record. The listed applicant is Shantou T&K Medical Equipment Factory Co.,Ltd. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K210380. 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 Medical surgical mask?

Medical surgical mask is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Shantou T&K Medical Equipment Factory Co.,Ltd. The 510(k) number is K210380.

When did Medical surgical mask receive FDA 510(k) clearance?

Medical surgical mask received FDA 510(k) clearance on 2021-07-08, under 510(k) number K210380.

Who is the listed applicant for Medical surgical mask?

The FDA 510(k) record lists Shantou T&K Medical Equipment Factory Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical surgical mask?

The FDA product code for Medical surgical mask is FXX.

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Dispositivos relacionados (Código: FXX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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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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