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FDA 510(k)

LM Surgical Mask Level 3, LM Surgical Mask Level 2,

N.º K: K211378 · 2021-12-16

SolicitanteLiberty Mask, LLC
Fecha de decisión2021-12-16
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

LM Surgical Mask Level 3, LM Surgical Mask Level 2, is the device name listed in this FDA 510(k) record. The listed applicant is Liberty Mask, LLC. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K211378. 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 LM Surgical Mask Level 3, LM Surgical Mask Level 2,?

LM Surgical Mask Level 3, LM Surgical Mask Level 2, is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is Liberty Mask, LLC. The 510(k) number is K211378.

When did LM Surgical Mask Level 3, LM Surgical Mask Level 2, receive FDA 510(k) clearance?

LM Surgical Mask Level 3, LM Surgical Mask Level 2, received FDA 510(k) clearance on 2021-12-16, under 510(k) number K211378.

Who is the listed applicant for LM Surgical Mask Level 3, LM Surgical Mask Level 2,?

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

What is the FDA product code for LM Surgical Mask Level 3, LM Surgical Mask Level 2,?

The FDA product code for LM Surgical Mask Level 3, LM Surgical Mask Level 2, 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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