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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 K221173
Device Name Surgical Mask (Model: 0868F, 0866F)
Applicant
Jiangxi Sanhao Medical Instruments Co.,Ltd
Chengxi Industrial Park, Jishui County, Ji'An City
Ji'An,  CN 331699
Applicant Contact Jiali Chen
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number878.4040
Classification Product Code
FXX  
Date Received04/25/2022
Decision Date 07/06/2022
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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