Surgical Mask (Model: 0868F, 0866F)

Mask, Surgical

Jiangxi SanHao Medical Instruments Co.,Ltd

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).

Pre-market Notification Details

Device IDK221173
510k NumberK221173
Device Name:Surgical Mask (Model: 0868F, 0866F)
ClassificationMask, Surgical
Applicant Jiangxi SanHao Medical Instruments Co.,Ltd Chengxi Industrial Park, Jishui County, Ji'an City Ji'an,  CN 331699
ContactJiali Chen
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou,  CN
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-25
Decision Date2022-07-06

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