The following data is part of a premarket notification filed by Promepla Sam with the FDA for Rocajj Soft Stents.
| Device ID | K173734 |
| 510k Number | K173734 |
| Device Name: | RocaJJ Soft Stents |
| Classification | Stent, Ureteral |
| Applicant | Promepla SAM 9 Avenue Albert II Monaco, MC 98000 |
| Contact | Alexandre Bareille |
| Correspondent | Alexandre Bareille Promepla 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 | 2017-12-06 |
| Decision Date | 2018-03-12 |
| Summary: | summary |