The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Wire, Guide, Catheter.
| Device ID | K850829 |
| 510k Number | K850829 |
| Device Name: | WIRE, GUIDE, CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jim Klosterman |
| Correspondent | Jim Klosterman LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-06-26 |