The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for Horizon (methafilcon A) Daily Wear Sphere And Toric Contact Lenses.
| Device ID | K031774 |
| 510k Number | K031774 |
| Device Name: | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESTCON CONTACT LENS CO., INC. 611 EISENHAUER ST. Grand Junction, CO 81505 |
| Contact | Carol Nobel |
| Correspondent | Carol Nobel 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 | 2003-06-09 |
| Decision Date | 2004-02-20 |
| Summary: | summary |