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FDA 510(k)

Mascarilla médica desechable de 3 capas

N.º K: K223045 · 2022-12-07

SolicitanteWealth Lead Industrial Limited
Fecha de decisión2022-12-07
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

3-Ply Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wealth Lead Industrial Limited. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223045. 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 3-Ply Disposable Medical Mask?

3-Ply Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Wealth Lead Industrial Limited. The 510(k) number is K223045.

When did 3-Ply Disposable Medical Mask receive FDA 510(k) clearance?

3-Ply Disposable Medical Mask received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223045.

Who is the listed applicant for 3-Ply Disposable Medical Mask?

The FDA 510(k) record lists Wealth Lead Industrial Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-Ply Disposable Medical Mask?

The FDA product code for 3-Ply Disposable Medical 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

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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