The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for Horizon 59 Oasis (hioxifilcon A) Daily Wear Contact Lenses.
| Device ID | K043540 |
| 510k Number | K043540 |
| Device Name: | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES |
| 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 | 2004-12-22 |
| Decision Date | 2005-02-01 |
| Summary: | summary |