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).
|Device Name:||Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)|
|Applicant||Zhanjiang Star Enterprise Co., Ltd NO.1, West Jinhua Rd. Zhanjiang, CN 524094|
Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755
|CFR Regulation Number||876.5130 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|