The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Hydrasoft (east) And Hydrasoft Toric(east) (methafilcon B) Daily Wear Soft Hydrophilic Contact Lens.
| Device ID | K962185 |
| 510k Number | K962185 |
| Device Name: | HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 200 WILLOWBROOK OFFICE PARK Fairport, NY 14450 -0000 |
| Contact | Bernard Hallatt |
| Correspondent | Bernard Hallatt COOPERVISION, INC. 200 WILLOWBROOK OFFICE PARK Fairport, NY 14450 -0000 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-06 |
| Decision Date | 1996-12-17 |
| Summary: | summary |