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FDA 510(k)

Máscara Cirúrgica UNIWEB, Modelo: Nível ASTM 1, Máscara Cirúrgica UNIWEB, Modelo: Nível ASTM 2

Número K: K210513 · 2021-09-29

RequerenteUniversal Incorporation
Data da decisão2021-09-29
Código do produtoFXX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Fonte oficial

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