The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for Horizon 38 (clear) And Horizon 38 Westint (tinted).
| Device ID | K023530 |
| 510k Number | K023530 |
| Device Name: | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESTCON CONTACT LENS CO., INC. 611 EISENHAUER ST. Grand Junction, CO 81505 |
| Contact | Carol Noble |
| Correspondent | Carol Noble WESTCON CONTACT LENS CO., INC. 611 EISENHAUER ST. Grand Junction, CO 81505 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-21 |
| Decision Date | 2002-11-26 |
| Summary: | summary |