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

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 Level 3 Fluid Resistant Procedure/surgical Mask (model:15604f, 1570f).

Pre-market Notification Details

Device IDK211827
510k NumberK211827
Device Name:Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
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 Date2021-09-23

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