The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Mandrel Guidewires Or M-wire.
| Device ID | K080508 |
| 510k Number | K080508 |
| Device Name: | MANDREL GUIDEWIRES OR M-WIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | LAKE REGION MEDICAL 340 LAKE HAZELTINE DRIVE Chaska, MN 55318 |
| Contact | Karen Mortensen |
| Correspondent | Karen Mortensen LAKE REGION MEDICAL 340 LAKE HAZELTINE DRIVE Chaska, MN 55318 |
| Product Code | OCY |
| Subsequent Product Code | EZB |
| Subsequent Product Code | FAD |
| Subsequent Product Code | FGE |
| Subsequent Product Code | GCA |
| Subsequent Product Code | KNY |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-03-21 |
| Summary: | summary |