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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Straight
510(k) Number K212430
Device Name BONREE Nelaton Catheter
Applicant
Bonree Medical Co., Ltd
No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang
Zhongshan,  CN 528451
Applicant Contact He Hongbo
Correspondent
Bonree Medical Co., Ltd
No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang
Zhongshan,  CN 528451
Correspondent Contact He Hongbo
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Code
EZC  
Date Received08/04/2021
Decision Date 04/29/2022
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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