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FDA 510(k)

UNIWEB Surgical Mask, Modelo: ASTM Level 1, UNIWEB Surgical Mask, Modelo: ASTM Level 2

N.º K: K210513 · 2021-09-29

SolicitanteUniversal Incorporation
Fecha de decisión2021-09-29
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 is the device name listed in this FDA 510(k) record. The listed applicant is Universal Incorporation. It received FDA 510(k) clearance on 2021-09-29 under 510(k) number K210513. 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 UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2?

UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 is a medical device that received FDA 510(k) clearance on 2021-09-29. The listed applicant is Universal Incorporation. The 510(k) number is K210513.

When did UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 receive FDA 510(k) clearance?

UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 received FDA 510(k) clearance on 2021-09-29, under 510(k) number K210513.

Who is the listed applicant for UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2?

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

What is the FDA product code for UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2?

The FDA product code for UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM 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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