Disposable Medical Surgical Mask

Mask, Surgical

Chongqing COE Display Technology Co., Ltd.

The following data is part of a premarket notification filed by Chongqing Coe Display Technology Co., Ltd. with the FDA for Disposable Medical Surgical Mask.

Pre-market Notification Details

Device IDK202759
510k NumberK202759
Device Name:Disposable Medical Surgical Mask
ClassificationMask, Surgical
Applicant Chongqing COE Display Technology Co., Ltd. No. 3, Tonggui Avenue, Yufengshan Town, Yubei District Chongqing,  CN 401120
ContactLiu Qingjun
CorrespondentJames Tsai
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen,  CN 518000
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-04-21

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