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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 K202640
Device Name Surgical Mask
Applicant
Jiangsu Medpure Biological Technology Co., Ltd.
No. 1 Beiyang Road, Hexi Village, Zouqu Town
ChangZhou,  CN 213144
Applicant Contact Jianwen Fei
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/11/2020
Decision Date 01/22/2021
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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