The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for Horizon 55 Bi-con.
| Device ID | K945365 |
| 510k Number | K945365 |
| Device Name: | HORIZON 55 BI-CON |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESTCON CONTACT LENS CO., INC. 715 HORIZON DR. #126 Grand Junction, CO 81506 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing WESTCON CONTACT LENS CO., INC. 715 HORIZON DR. #126 Grand Junction, CO 81506 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-02 |
| Decision Date | 1994-12-28 |