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 ID | K170233 |
| 510k Number | K170233 |
| Device Name: | Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) |
| Classification | Catheter, Straight |
| Applicant | Zhanjiang Star Enterprise Co., Ltd NO.1, West Jinhua Rd. Zhanjiang, CN 524094 |
| Contact | Rongsheng Tang |
| Correspondent | Elly Xu Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, CN Gd755 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2017-10-13 |
| Summary: | summary |