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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 K210372
Device Name Disposable Surgical Mask
Applicant
Dongguan Shin YI Healthcare Products Factory
# 17 Ban Hu Rd., Huang Jiang Town
Dong Guan,  CN 523750
Applicant Contact Zhao Shuge
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 51800
Correspondent Contact Joyce Yang
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/08/2021
Decision Date 06/07/2021
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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