| K-number | K211819 |
| Device name | DiLumen C2 and Tool Mount |
| Applicant | Lumendi, LLC |
| Product code | FDF |
| Device class | Class II |
| Decision date | Oct 22, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov