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FDA 510(k)

CPL Surgical Face Mask

N.º K: K213136 · 2021-12-24

SolicitanteControl Print Limited
Fecha de decisión2021-12-24
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

CPL Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Control Print Limited. It received FDA 510(k) clearance on 2021-12-24 under 510(k) number K213136. 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 CPL Surgical Face Mask?

CPL Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-12-24. The listed applicant is Control Print Limited. The 510(k) number is K213136.

When did CPL Surgical Face Mask receive FDA 510(k) clearance?

CPL Surgical Face Mask received FDA 510(k) clearance on 2021-12-24, under 510(k) number K213136.

Who is the listed applicant for CPL Surgical Face Mask?

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

What is the FDA product code for CPL Surgical Face Mask?

The FDA product code for CPL Surgical Face 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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