The following data is part of a premarket notification filed by Eagle Vision, Inc. with the FDA for Eagle Vision Freeman Radiopague Punctum Plug.
| Device ID | K905427 |
| 510k Number | K905427 |
| Device Name: | EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG |
| Classification | Plug, Punctum |
| Applicant | EAGLE VISION, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | Donald Mackeen |
| Correspondent | Donald Mackeen EAGLE VISION, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| 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 | 1990-12-04 |
| Decision Date | 1991-06-06 |