The following data is part of a premarket notification filed by Eagle Vision, Inc. with the FDA for Eaglevision Gellanserts, Model Ref 0040.
| Device ID | K053333 |
| 510k Number | K053333 |
| Device Name: | EAGLEVISION GELLANSERTS, MODEL REF 0040 |
| Classification | Plug, Punctum |
| Applicant | EAGLE VISION, INC. 8500 WOLF LAKE DR. SUITE 110 Memphis, TN 38133 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb EAGLE VISION, INC. 8500 WOLF LAKE DR. SUITE 110 Memphis, TN 38133 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-01 |
| Decision Date | 2006-05-02 |
| Summary: | summary |