Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)

Catheter, Straight

Zhanjiang Star Enterprise Co., Ltd

The following data is part of a premarket notification filed by Zhanjiang Star Enterprise Co., Ltd with the FDA for Diposable Urinary Catheter (pvc Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter).

Pre-market Notification Details

Device IDK170233
510k NumberK170233
Device Name:Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
ClassificationCatheter, Straight
Applicant Zhanjiang Star Enterprise Co., Ltd NO.1, West Jinhua Rd. Zhanjiang,  CN 524094
ContactRongsheng Tang
CorrespondentElly Xu
Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen,  CN Gd755
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-25
Decision Date2017-10-13
Summary:summary

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