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FDA 510(k)

Secure Wear USA Surgical Face Mask

Número K: K203101 · 2021-03-31

RequerenteSecured Ortho Manufacturing of America, LLC
Data da decisão2021-03-31
Código do produtoFXX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Secure Wear USA Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Secured Ortho Manufacturing of America, LLC. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K203101. 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 Secure Wear USA Surgical Face Mask?

Secure Wear USA Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Secured Ortho Manufacturing of America, LLC. The 510(k) number is K203101.

When did Secure Wear USA Surgical Face Mask receive FDA 510(k) clearance?

Secure Wear USA Surgical Face Mask received FDA 510(k) clearance on 2021-03-31, under 510(k) number K203101.

Who is the listed applicant for Secure Wear USA Surgical Face Mask?

The FDA 510(k) record lists Secured Ortho Manufacturing of America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Secure Wear USA Surgical Face Mask?

The FDA product code for Secure Wear USA Surgical Face Mask is FXX.

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Dispositivos Relacionados (Código: FXX)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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