FDA 510(k)

Sparta 3-Ply Surgical Disposable Face Mask

Número K: K220378 · 2022-06-30

Data da decisão2022-06-30

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sparta 3-Ply Surgical Disposable Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Sparta East, LLC. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K220378. 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 Sparta 3-Ply Surgical Disposable Face Mask?

Sparta 3-Ply Surgical Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Sparta East, LLC. The 510(k) number is K220378.

When did Sparta 3-Ply Surgical Disposable Face Mask receive FDA 510(k) clearance?

Sparta 3-Ply Surgical Disposable Face Mask received FDA 510(k) clearance on 2022-06-30, under 510(k) number K220378.

Who is the listed applicant for Sparta 3-Ply Surgical Disposable Face Mask?

The FDA 510(k) record lists Sparta East, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sparta 3-Ply Surgical Disposable Face Mask?

The FDA product code for Sparta 3-Ply Surgical Disposable Face Mask is FXX.

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