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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 K243535
Device Name Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd.
3 Floor, Bldg. #1, 4299 Jindu Rd. Minhang District
Shanghai,  CN 201108
Applicant Contact Die Li
Correspondent
Shanghai SeeGen Photoelectric Technology Co., Ltd.
3 Floor, Bldg. #1, 4299 Jindu Rd. Minhang District
Shanghai,  CN 201108
Correspondent Contact Die Li
Regulation Number876.1500
Classification Product Code
FBN  
Date Received11/15/2024
Decision Date 03/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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