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FDA 510(k)

Freudenberg Surgical Mask

N.º K: K210063 · 2021-02-05

SolicitanteFreudenberg Performance Materials LP
Fecha de decisión2021-02-05
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Freudenberg Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Performance Materials LP. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K210063. 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 Freudenberg Surgical Mask?

Freudenberg Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Freudenberg Performance Materials LP. The 510(k) number is K210063.

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

Freudenberg Surgical Mask received FDA 510(k) clearance on 2021-02-05, under 510(k) number K210063.

Who is the listed applicant for Freudenberg Surgical Mask?

The FDA 510(k) record lists Freudenberg Performance Materials LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freudenberg Surgical Mask?

The FDA product code for Freudenberg Surgical Mask is FXX.

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Dispositivos relacionados (Código: FXX)

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Fuente oficial

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