FDA 510(k)

Velguard Surgical Face Mask

Número K: K210761 · 2021-07-16

RequerenteEsstee Exports Health Care Division

Data da decisão2021-07-16

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Velguard Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Esstee Exports Health Care Division. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K210761. 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 Velguard Surgical Face Mask?

Velguard Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Esstee Exports Health Care Division. The 510(k) number is K210761.

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

Velguard Surgical Face Mask received FDA 510(k) clearance on 2021-07-16, under 510(k) number K210761.

Who is the listed applicant for Velguard Surgical Face Mask?

The FDA 510(k) record lists Esstee Exports Health Care Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velguard Surgical Face Mask?

The FDA product code for Velguard Surgical Face Mask is FXX.

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