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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 K202161
Device Name Surgical Face Mask
Applicant
Hunan EEXI Technology & Service Co., Ltd.
No.6 North of Pingtou Road, Liuyang Hi-Tech Industrial
Development Zone
Liuyang,  CN 410300
Applicant Contact Zhang Xianliang
Correspondent
Shenzhen Joyantech Consulting Co.,Ltd.
1713A, 17th Floor, Block A, Zhongguan Times Square,
Nanshan District
Shenzhen,  CN 518100
Correspondent Contact Joyce Joyce
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/03/2020
Decision Date 03/10/2021
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
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