FDA 510(k)

Medical Surgical Mask-Model MP002-5, MP002-6

Número K: K202577 · 2021-01-11

RequerenteJiangmen Sure&Me Medical Product Co., Ltd.

Data da decisão2021-01-11

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Surgical Mask-Model MP002-5, MP002-6 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangmen Sure&Me Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K202577. 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 Surgical Mask-Model MP002-5, MP002-6?

Medical Surgical Mask-Model MP002-5, MP002-6 is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Jiangmen Sure&Me Medical Product Co., Ltd.. The 510(k) number is K202577.

When did Medical Surgical Mask-Model MP002-5, MP002-6 receive FDA 510(k) clearance?

Medical Surgical Mask-Model MP002-5, MP002-6 received FDA 510(k) clearance on 2021-01-11, under 510(k) number K202577.

Who is the listed applicant for Medical Surgical Mask-Model MP002-5, MP002-6?

The FDA 510(k) record lists Jiangmen Sure&Me Medical Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Surgical Mask-Model MP002-5, MP002-6?

The FDA product code for Medical Surgical Mask-Model MP002-5, MP002-6 is FXX.

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