The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Preference 60 And Preference 60 Toric.
Device ID | K963013 |
510k Number | K963013 |
Device Name: | PREFERENCE 60 AND PREFERENCE 60 TORIC |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | COOPERVISION, INC. 711 NORTH RD. Scottsville, NY 14546 |
Contact | Bernard F Hallatt |
Correspondent | Bernard F Hallatt 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 | 1996-07-30 |
Decision Date | 1997-12-19 |