The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for W-55 (methafilcon A) Clear And Visibility Tinted Lens Blank And Horizon 55 Soft (clear) And Horizon 55 Westint (tinted).
| Device ID | K992010 |
| 510k Number | K992010 |
| Device Name: | W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-15 |
| Decision Date | 1999-06-29 |
| Summary: | summary |