The following data is part of a premarket notification filed by Neuramedica Inc with the FDA for Durafuse Clip And Applier System.
| Device ID | K213813 |
| 510k Number | K213813 |
| Device Name: | DuraFuse Clip And Applier System |
| Classification | Clip, Implantable |
| Applicant | NeuraMedica Inc 402 Beavercreek Road, Suite 110 Oregon City, OR 97045 |
| Contact | Rachel Dreilinger |
| Correspondent | Rachel Dreilinger NeuraMedica Inc 402 Beavercreek Road, Suite 110 Oregon City, OR 97045 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-07 |
| Decision Date | 2022-07-22 |