The following data is part of a premarket notification filed by Bonree Medical Co., Ltd with the FDA for Bonree Nelaton Catheter.
| Device ID | K212430 |
| 510k Number | K212430 |
| Device Name: | BONREE Nelaton Catheter |
| Classification | Catheter, Straight |
| Applicant | Bonree Medical Co., Ltd No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang Zhongshan, CN 528451 |
| Contact | He Hongbo |
| Correspondent | He Hongbo Bonree Medical Co., Ltd No.4 Longzhu Garden, Wanmu Industrial Estate, Nanlang Zhongshan, CN 528451 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2022-04-29 |