Disposable Medical Face Mask

Mask, Surgical

Guangzhou Mei Yi Kang Medical Technology CO., LTD.

The following data is part of a premarket notification filed by Guangzhou Mei Yi Kang Medical Technology Co., Ltd. with the FDA for Disposable Medical Face Mask.

Pre-market Notification Details

Device IDK203646
510k NumberK203646
Device Name:Disposable Medical Face Mask
ClassificationMask, Surgical
Applicant Guangzhou Mei Yi Kang Medical Technology CO., LTD. No. 43-31 Baofeng East Road, JinShi North Avenue, Shiling Town, Huada District Guangzhou,  CN 510800
ContactLou Yonghui
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou,  CN 510000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-14
Decision Date2021-04-22

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