The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Hydrophilic Coated Guidewire.
| Device ID | K981667 |
| 510k Number | K981667 |
| Device Name: | HYDROPHILIC COATED GUIDEWIRE |
| Classification | Accessories, Catheter, G-u |
| 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 | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1998-06-05 |
| Summary: | summary |