The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Modified Hydrophilic Coated Guidewire (stainless Steel Core).
| Device ID | K003483 |
| 510k Number | K003483 |
| Device Name: | MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-09 |
| Decision Date | 2000-12-06 |