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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 K202314
Device Name Procedure face mask (Model: KKF-2A)
Applicant
Han Zhaoqing Sporting Goods Company Limited
NO.2-1, Kang tai Street, High-tech zone, Zhaoqing City,
Guangdong ,China
Zhaoqing,  CN 526238
Applicant Contact Zhang Ming
Correspondent
Share Info (Guangzhou) Medical Consultant Ltd.
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road,
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Cassie Lee
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/17/2020
Decision Date 01/13/2021
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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