Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

Mask, Surgical

Zhejiang Lanhine Medical Products LTD

The following data is part of a premarket notification filed by Zhejiang Lanhine Medical Products Ltd with the FDA for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask.

Pre-market Notification Details

Device IDK211832
510k NumberK211832
Device Name:Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
ClassificationMask, Surgical
Applicant Zhejiang Lanhine Medical Products LTD 1989 Cidong Road, Cidongbinhai District Cixi,  CN 315300
ContactJerry Gu
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-14
Decision Date2021-09-08

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