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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 K202205
Device Name Surgical Face Mask
Applicant
Jiangsu Micsafe Medical Technology Co., Ltd
Xituan Industrial Park, Dafeng District, Yancheng City,
Jiangsu Province, China
Yancheng,  CN 224125
Applicant Contact Tony Yang
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 Received08/05/2020
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
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