| K-number | K894592 |
| Device name | LAMANO DIRECTORS |
| Applicant | Marlo Surgical Technology |
| Product code | GCM |
| Device class | Class II |
| Decision date | Sep 8, 1989 |
| 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