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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastroscope and accessories, flexible/rigid
510(k) Number K192704
Device Name Endofresh Digestive Endoscopy System
Applicant
HuiZhou Xzing Technology Co., Ltd.
4th Floor, Building D, S-16-2 Southern park
HuiNan Hi-tech Industrial Park
Huizhou,  CN 516000
Applicant Contact Yonglin Ni
Correspondent
Mid-Link Consulting Co., Ltd
P.O Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received09/27/2019
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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