The following data is part of a premarket notification filed by Ocu-ease Optical Products, Inc. with the FDA for Ocu-flex 55 Spherical, Toric,thin Zone Toric,aspherical,toric Aspherical And Thin Zone Toric Aspherical (methafilcon A)s.
| Device ID | K011577 |
| 510k Number | K011577 |
| Device Name: | OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S |
| 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 | 2001-05-22 |
| Decision Date | 2001-06-19 |
| Summary: | summary |