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FDA 510(k)

ASM-301 Nivel 3 Mascara Quirúrgica

N.º K: K211440 · 2021-06-02

SolicitanteAmerican Surgical Mask Company, LLC
Fecha de decisión2021-06-02
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

ASM-301 Level 3 Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Mask Company, LLC. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211440. 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 ASM-301 Level 3 Surgical Mask?

ASM-301 Level 3 Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is American Surgical Mask Company, LLC. The 510(k) number is K211440.

When did ASM-301 Level 3 Surgical Mask receive FDA 510(k) clearance?

ASM-301 Level 3 Surgical Mask received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211440.

Who is the listed applicant for ASM-301 Level 3 Surgical Mask?

The FDA 510(k) record lists American Surgical Mask Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASM-301 Level 3 Surgical Mask?

The FDA product code for ASM-301 Level 3 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

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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