FDA 510(k)

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)

Numéro K : K211750 · 2021-12-20

DemandeurNational Bridge Industrial (S.Z.) Co., Ltd.

Date de décision2021-12-20

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is National Bridge Industrial (S.Z.) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K211750. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)?

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is National Bridge Industrial (S.Z.) Co., Ltd.. The 510(k) number is K211750.

When did Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) receive FDA 510(k) clearance?

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) received FDA 510(k) clearance on 2021-12-20, under 510(k) number K211750.

Who is the listed applicant for Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)?

The FDA 510(k) record lists National Bridge Industrial (S.Z.) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)?

The FDA product code for Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) is FXX.

Essais cliniques associés

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Dispositifs connexes (Code : FXX)

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Source officielle

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