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FDA 510(k)

Savvy Mask - Level 3 Surgical Face Mask

N.º K: K213406 · 2021-11-18

SolicitanteTexas Medplast, LLC
Fecha de decisión2021-11-18
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Savvy Mask - Level 3 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medplast, LLC. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213406. 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 Savvy Mask - Level 3 Surgical Face Mask?

Savvy Mask - Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Texas Medplast, LLC. The 510(k) number is K213406.

When did Savvy Mask - Level 3 Surgical Face Mask receive FDA 510(k) clearance?

Savvy Mask - Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213406.

Who is the listed applicant for Savvy Mask - Level 3 Surgical Face Mask?

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

What is the FDA product code for Savvy Mask - Level 3 Surgical Face Mask?

The FDA product code for Savvy Mask - Level 3 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

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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