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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 K202714
Device Name Medical Face Mask
Applicant
Chongqing Chaoke Industry Development Co., Ltd.
C31, Yangtze River Industry Park, Tea Garden New Zone,
Nan'An District
Chongqing,  CN 400067
Applicant Contact Liu Xincheng
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/16/2020
Decision Date 06/11/2021
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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