The following data is part of a premarket notification filed by Hangzhou Jimushi Meditech Co., Ltd. with the FDA for Jimushi Sterile Urethral Catheter For Single Use.
| Device ID | K200134 |
| 510k Number | K200134 |
| Device Name: | Jimushi Sterile Urethral Catheter For Single Use |
| Classification | Catheter, Urethral |
| Applicant | Hangzhou Jimushi Meditech Co., Ltd. 5F, Building 2, No. 12 Longtan Road, Cangqian Street, Yuhang District Hangzhou, CN |
| Contact | Fenlong Wu |
| Correspondent | Wei Shan Hsu Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, CN |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-06-01 |