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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K202759
Device Name Disposable medical surgical mask
Applicant
Chongqing Coe Display Technology Co., Ltd.
# 3, Tonggui Ave., Yufengshan Town, Yubei District
Chongqing,  CN 401120
Applicant Contact Liu Qingjun
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact James Tsai
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/21/2020
Decision Date 04/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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