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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 K210007
Device Name Face Mask
Applicant
Jinhua Jingdi Medical Supplies Co., Ltd.
Bldg. 2, Ditian Function, Xiaoshun Town, Jindongzone
Jinhua,  CN 321000
Applicant Contact Hu Xiaojiang
Correspondent
Shanghai Mind-Link Business Consulting Co., Ltd.
Rm. A08, Floor 14th, No 699, Jiaozhou Rd., Jingan District
Shanghai,  CN 200040
Correspondent Contact Julie Chen
Regulation Number878.4040
Classification Product Code
FXX  
Date Received01/04/2021
Decision Date 04/23/2021
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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