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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, Bldg. 2, # 1, Mawu Rd.
Baoan Community, Yuanshan St., Longgang Dis
Shenzhen,  CN 518100
Applicant Contact Jiang Yuanning
Correspondent
Shenzhen Chonconn Medical Consulting Co., Ltd.
Rm. 504, Block C
# 1029 Nanhai Ave., 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
Predetermined Change
Control Plan Authorized		 No
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