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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(k) Number K241532
Device Name Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
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
FET  
Subsequent Product Code
KQM  
Date Received05/30/2024
Decision Date 10/22/2024
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
Predetermined Change
Control Plan Authorized		 No
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