The following data is part of a premarket notification filed by Westcon Contact Lens Co., Inc. with the FDA for Horizon/westhin 38 Sofblu (polymacon) Soft (spherical & Toric) Daily Wear Contact Lens (tinted, Lathe-cut From Lens Blan.
| Device ID | K963837 |
| 510k Number | K963837 |
| Device Name: | HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLAN |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | WESTCON CONTACT LENS CO., INC. 611 EISENHAUER ST. Grand Junction, CO 81505 |
| Contact | Bernice Barnard |
| Correspondent | Bernice Barnard 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 | 1996-09-24 |
| Decision Date | 1996-12-20 |