BONREE Nelaton Catheter

Catheter, Straight

Bonree Medical Co., Ltd

The following data is part of a premarket notification filed by Bonree Medical Co., Ltd with the FDA for Bonree Nelaton Catheter.

Pre-market Notification Details

Device IDK212430
510k NumberK212430
Device Name:BONREE Nelaton Catheter
ClassificationCatheter, Straight
Applicant Bonree Medical Co., Ltd No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang Zhongshan,  CN 528451
ContactHe Hongbo
CorrespondentHe Hongbo
Bonree Medical Co., Ltd No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang Zhongshan,  CN 528451
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-04
Decision Date2022-04-29

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