The following data is part of a premarket notification filed by Jiangxi Sanhao Medical Instruments Co.,ltd with the FDA for Surgical Mask (model: 0868f, 0866f).
|Device Name:||Surgical Mask (Model: 0868F, 0866F)|
|Applicant||Jiangxi SanHao Medical Instruments Co.,Ltd Chengxi Industrial Park, Jishui County, Ji'an City Ji'an, CN 331699|
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|