The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Tetrafilcon A Hydrophilic Contact Lenses.
| Device ID | K950968 |
| 510k Number | K950968 |
| Device Name: | TETRAFILCON A HYDROPHILIC CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 711 NORTH RD. Scottsville, NY 14546 |
| Contact | Bonnie Tsymbal |
| Correspondent | Bonnie Tsymbal COOPERVISION, INC. 711 NORTH RD. Scottsville, NY 14546 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-01 |
| Decision Date | 1995-07-25 |