Surgical Face Mask

Mask, Surgical

Hunan EEXI Technology & Service Co., Ltd.

The following data is part of a premarket notification filed by Hunan Eexi Technology & Service Co., Ltd. with the FDA for Surgical Face Mask.

Pre-market Notification Details

Device IDK202161
510k NumberK202161
Device Name:Surgical Face Mask
ClassificationMask, Surgical
Applicant Hunan EEXI Technology & Service Co., Ltd. No.6 North Of Pingtou Road, Liuyang Hi-Tech Industrial Development Zone Liuyang,  CN 410300
ContactZhang Xianliang
CorrespondentJoyce Joyce
Shenzhen Joyantech Consulting Co.,Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518100
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2021-03-10

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