FDA 510(k)

ASM-301 Máscara Cirúrgica Nível 3

Número K: K211440 · 2021-06-02

RequerenteAmerican Surgical Mask Company, LLC

Data da decisão2021-06-02

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ASM-301 Level 3 Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Mask Company, LLC. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K211440. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ASM-301 Level 3 Surgical Mask?

ASM-301 Level 3 Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is American Surgical Mask Company, LLC. The 510(k) number is K211440.

When did ASM-301 Level 3 Surgical Mask receive FDA 510(k) clearance?

ASM-301 Level 3 Surgical Mask received FDA 510(k) clearance on 2021-06-02, under 510(k) number K211440.

Who is the listed applicant for ASM-301 Level 3 Surgical Mask?

The FDA 510(k) record lists American Surgical Mask Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASM-301 Level 3 Surgical Mask?

The FDA product code for ASM-301 Level 3 Surgical Mask is FXX.

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