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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 K202331
Device Name Medical Face Mask
Applicant
Gemtier Medical (Shanghai), Inc.
#18 Jianding Rd., Fengjing Town, Jinshan District
Shanghai,  CN 201502
Applicant Contact Li Zhiqing
Correspondent
Shanghai Medical Business Consulting Co., Ltd.
# 170 Huajiang Rd., Jiading District
Shanghai,  CN 201803
Correspondent Contact Julie Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/17/2020
Decision Date 02/02/2021
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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