FDA 510(k)

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

Número K: K211832 · 2021-09-08

RequerenteZhejiang Lanhine Medical Products, Ltd.

Data da decisão2021-09-08

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K211832. 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 Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211832.

When did Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask receive FDA 510(k) clearance?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211832.

Who is the listed applicant for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA 510(k) record lists Zhejiang Lanhine Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is FXX.

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Outros registros que listam Zhejiang Lanhine Medical Products, Ltd. como candidato(a)

K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

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