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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 K202107
Device Name Medical Protective Mask
Applicant
Guangdong Kingfa Sci. & Tech.Co., Ltd.
28 Delong Ave., Shijiao Town, Qingcheng District
Qingyuan City,  CN 511500
Applicant Contact Yu Xiaoge
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plaza, Shuixi Rd.,
Huangpu District
Guangzhou,  CN 510700
Correspondent Contact Cassie Lee
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/29/2020
Decision Date 01/15/2021
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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