The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Frequency 55 Uv (methafilcon A) Soft (hydrophlic) Contact Lens For Daily Wear.
Device ID | K020392 |
510k Number | K020392 |
Device Name: | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR |
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 | 2002-02-06 |
Decision Date | 2002-04-26 |
Summary: | summary |