The following data is part of a premarket notification filed by Lake Region Medical, Inc. with the FDA for Pre-formed Guidewires.
| Device ID | K130798 |
| 510k Number | K130798 |
| Device Name: | PRE-FORMED GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MEDICAL, INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Mathew Pexa |
| Correspondent | Mathew Pexa LAKE REGION MEDICAL, INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-22 |
| Decision Date | 2013-08-23 |
| Summary: | summary |