FDA 510(k)

Medical Face Masks

Número K: K202627 · 2021-02-03

RequerenteGuilin Hbm Sanitary Protections, Inc.

Data da decisão2021-02-03

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Face Masks is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Hbm Sanitary Protections, Inc.. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K202627. 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 Medical Face Masks?

Medical Face Masks is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Guilin Hbm Sanitary Protections, Inc.. The 510(k) number is K202627.

When did Medical Face Masks receive FDA 510(k) clearance?

Medical Face Masks received FDA 510(k) clearance on 2021-02-03, under 510(k) number K202627.

Who is the listed applicant for Medical Face Masks?

The FDA 510(k) record lists Guilin Hbm Sanitary Protections, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Masks?

The FDA product code for Medical Face Masks is FXX.

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