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).
|Device Name:||Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)|
|Applicant||Zhejiang Lanhine Medical Products LTD 1989 Cidong Road, Cidongbinhai District Cixi, CN 315300|
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|