The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Methafilcon A Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 Uv (to Be Marketed Yr. 2000), Frequency 55 Asp.
| Device ID | K993252 |
| 510k Number | K993252 |
| Device Name: | METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP |
| Classification | Lens, Contact, (disposable) |
| 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 | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-28 |
| Decision Date | 1999-11-24 |
| Summary: | summary |