| K-number | K891339 |
| Device name | IRRI-FLO IRRIGATION DELIVERY SYSTEM |
| Applicant | Surgitek |
| Product code | OCX |
| Device class | Class II |
| Decision date | Jun 2, 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