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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K231118
Device Name Cystoscope System
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
415,416-1,516-1, Building 2, No. 1, Mawu Road
Baoan Community, Yuanshan Street, Longgang Dis
Shenzhen,  CN 518100
Applicant Contact Jiang Yuanning
Correspondent
Shenzhen Chonconn Medical Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Yang Jie
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received04/20/2023
Decision Date 11/13/2023
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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