The following data is part of a premarket notification filed by Rocamed Sam with the FDA for Jfil Ureteral Stents, Jfil Ureteral Stents Eco Kit.
| Device ID | K212868 |
| 510k Number | K212868 |
| Device Name: | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT |
| Classification | Stent, Ureteral |
| Applicant | Rocamed SAM 9 Avenue Albert II Monaco, MC 98000 |
| Contact | Tahiana Rasolofoniaina |
| Correspondent | Tahiana Rasolofoniaina Rocamed SAM 9 Avenue Albert II Monaco, MC 98000 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-09 |
| Decision Date | 2022-01-26 |