The following data is part of a premarket notification filed by Ocu-ease Optical Products, Inc. with the FDA for Ocu-flex-53 Thin Zone Toric And Thin Zone Toric Aspherical (ocufilcon) Soft Contact Lenses For Daily Wear.
| Device ID | K003996 |
| 510k Number | K003996 |
| Device Name: | OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES 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 | 2000-12-26 |
| Decision Date | 2001-02-21 |