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FDA 510(k)

Mascarilla quirúrgica de 3 capas (134252531)

N.º K: K231618 · 2023-07-28

SolicitanteOriginal Mattress Factory, Inc.
Fecha de decisión2023-07-28
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

3 Layer Surgical Mask (134252531) is the device name listed in this FDA 510(k) record. The listed applicant is Original Mattress Factory, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K231618. 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 Layer Surgical Mask (134252531)?

3 Layer Surgical Mask (134252531) is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Original Mattress Factory, Inc.. The 510(k) number is K231618.

When did 3 Layer Surgical Mask (134252531) receive FDA 510(k) clearance?

3 Layer Surgical Mask (134252531) received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231618.

Who is the listed applicant for 3 Layer Surgical Mask (134252531)?

The FDA 510(k) record lists Original Mattress Factory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Layer Surgical Mask (134252531)?

The FDA product code for 3 Layer Surgical Mask (134252531) 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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