The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Mandrel Guidewire.
| Device ID | K140482 |
| 510k Number | K140482 |
| Device Name: | MANDREL GUIDEWIRE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | LAKE REGION MEDICAL 340 LAKE HAZELTINE DRIVE Chaska, MN 55318 |
| Contact | Mathew Pexa |
| Correspondent | Mathew Pexa LAKE REGION MEDICAL 340 LAKE HAZELTINE DRIVE Chaska, MN 55318 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-26 |
| Decision Date | 2014-04-08 |
| Summary: | summary |