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FDA 510(k)

Single-use Surgical Mask

N.º K: K211773 · 2021-12-02

SolicitanteTaiwan Seafood and Fish Corporation
Fecha de decisión2021-12-02
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-use Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Seafood and Fish Corporation. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K211773. 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 Single-use Surgical Mask?

Single-use Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Taiwan Seafood and Fish Corporation. The 510(k) number is K211773.

When did Single-use Surgical Mask receive FDA 510(k) clearance?

Single-use Surgical Mask received FDA 510(k) clearance on 2021-12-02, under 510(k) number K211773.

Who is the listed applicant for Single-use Surgical Mask?

The FDA 510(k) record lists Taiwan Seafood and Fish Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Surgical Mask?

The FDA product code for Single-use Surgical 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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