The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Lake Region Manufacturing Guidewires.
| Device ID | K981326 |
| 510k Number | K981326 |
| Device Name: | LAKE REGION MANUFACTURING GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Kim E Aves |
| Correspondent | Kim E Aves LAKE REGION MFG., 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 | 1998-04-13 |
| Decision Date | 1998-07-10 |
| Summary: | summary |