Silicone Foley Catheter For Single Use

Catheter, Retention Type, Balloon

Changzhou Rongxin Medicine Minimal Invasion Technology

The following data is part of a premarket notification filed by Changzhou Rongxin Medicine Minimal Invasion Technology with the FDA for Silicone Foley Catheter For Single Use.

Pre-market Notification Details

Device IDK172807
510k NumberK172807
Device Name:Silicone Foley Catheter For Single Use
ClassificationCatheter, Retention Type, Balloon
Applicant Changzhou Rongxin Medicine Minimal Invasion Technology No. 8, Jianerkang Road, Industrial Concentration Area, Zhixi Town Jintan City,  CN 213251
ContactPing Liu
CorrespondentMike Gu
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9Th Floor, R&D Building, No. 26 Qinglan Street Panyu District Guangzhou,  CN 510006
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-18
Decision Date2018-06-04
Summary:summary

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