The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex.
Device ID | K000384 |
510k Number | K000384 |
Device Name: | FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-07 |
Decision Date | 2000-03-06 |