Lake Region Medical · Class II · Cleared Mar 21, 2008
| K-number | K080508 |
| Device name | MANDREL GUIDEWIRES OR M-WIRE |
| Applicant | Lake Region Medical |
| Product code | OCY |
| Device class | Class II |
| Decision date | Mar 21, 2008 |
| 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