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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 K202710
Device Name Disposable Medical Face Mask
Applicant
Wanxinda (Guangzhou) Technology Product Co., Ltd.
Ling Xi Rd., Accessory Section 2, Automobile Zone,
Huada District
Guangzhou,  CN 510800
Applicant Contact Zeng Xueping
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq., Nanshan
District
Shenzhen,  CN 518100
Correspondent Contact Joyce Yang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/16/2020
Decision Date 03/09/2021
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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