| K-number | K230644 |
| Device name | Signum opaque F |
| Applicant | Kulzer, LLC |
| Product code | EBF |
| Device class | Class II |
| Decision date | Sep 7, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 872.3690 |
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