The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Avaira (enfilcon A) Contact Lens.
Device ID | K113759 |
510k Number | K113759 |
Device Name: | AVAIRA (ENFILCON A) CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
Contact | Karin Gastineau |
Correspondent | Karin Gastineau COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-21 |
Decision Date | 2012-04-03 |
Summary: | summary |