Hangzhou Bever Medical Devices Co., Ltd. · Class II · Cleared Nov 27, 2019
| K-number | K192468 |
| Device name | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter |
| Applicant | Hangzhou Bever Medical Devices Co., Ltd. |
| Product code | GBM |
| Device class | Class II |
| Decision date | Nov 27, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
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