The following data is part of a premarket notification filed by Ocu-ease Optical Products, Inc. with the FDA for Tinted Ocu-flex 53 (occufilcon B) Soft Hydrophilic Contact Lens.
| Device ID | K960291 |
| 510k Number | K960291 |
| Device Name: | TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENS |
| 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 | 1996-01-22 |
| Decision Date | 1996-03-25 |
| Summary: | summary |