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FDA 510(k)

Mascarilla Quirúrgica AllureTM

N.º K: K212926 · 2022-09-16

SolicitanteAllure Gift Wraps Private Limited
Fecha de decisión2022-09-16
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

AllureTM Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Allure Gift Wraps Private Limited. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K212926. 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 AllureTM Surgical Mask?

AllureTM Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Allure Gift Wraps Private Limited. The 510(k) number is K212926.

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

AllureTM Surgical Mask received FDA 510(k) clearance on 2022-09-16, under 510(k) number K212926.

Who is the listed applicant for AllureTM Surgical Mask?

The FDA 510(k) record lists Allure Gift Wraps Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AllureTM Surgical Mask?

The FDA product code for AllureTM 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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