| K-number | K904669 |
| Device name | BALLOON CATHETERS |
| Applicant | Olympus Corp. |
| Product code | FGE |
| Device class | Class II |
| Decision date | Mar 15, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 876.5010 |
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