The following data is part of a premarket notification filed by Ocu-ease Optical Products, Inc. with the FDA for Ocu-flex-38 Keratoconus (polymacon) Soft Contact Lens For Daily Wear.
| Device ID | K992466 |
| 510k Number | K992466 |
| Device Name: | OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | OCU-EASE OPTICAL PRODUCTS, INC. 629 TENNENT AVE. Pinole, CA 94564 |
| Contact | Charles R Vermette |
| Correspondent | Charles R Vermette OCU-EASE OPTICAL PRODUCTS, INC. 629 TENNENT AVE. Pinole, CA 94564 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-23 |
| Decision Date | 1999-10-04 |
| Summary: | summary |