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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K222261
Device Name Flexible Video-Choledochoscope System
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd
3 Floor, Building No.1, 4299 JinDu Road, Minhang District
Shanghai,  CN 201108
Applicant Contact Yihua Ma
Correspondent
Shanghai SeeGen Photoelectric Technology Co., Ltd
3 Floor, Building No.1, 4299 JinDu Road, Minhang District
Shanghai,  CN 201108
Correspondent Contact Yihua Ma
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
FET   KQM   NTN  
Date Received07/28/2022
Decision Date 04/20/2023
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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