The following data is part of a premarket notification filed by I-see Vision Technology Inc with the FDA for Ezvue (ocufilcon D) Soft (hydrophilic) Contact Lens For Daily Wear.
Device ID | K082879 |
510k Number | K082879 |
Device Name: | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | I-SEE VISION TECHNOLOGY INC 2904 N.BOLDT DRIVE Flagstaff, AZ 86001 |
Contact | Jennifer Reich |
Correspondent | Jennifer Reich I-SEE VISION TECHNOLOGY INC 2904 N.BOLDT DRIVE Flagstaff, AZ 86001 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-09-29 |
Decision Date | 2009-06-16 |
Summary: | summary |