The following data is part of a premarket notification filed by Westcon Contact Lens Co. with the FDA for Westcon Horizon 49% (hioxifilcon B).
| Device ID | K080686 |
| 510k Number | K080686 |
| Device Name: | WESTCON HORIZON 49% (HIOXIFILCON B) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESTCON CONTACT LENS CO. 581 WHILES COURT Erie, CO 80516 -7225 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall WESTCON CONTACT LENS CO. 581 WHILES COURT Erie, CO 80516 -7225 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-11 |
| Decision Date | 2008-04-22 |
| Summary: | summary |