The following data is part of a premarket notification filed by Eagle Vision, Inc. with the FDA for Ev Monocanalicular Stent (tm).
| Device ID | K883233 |
| 510k Number | K883233 |
| Device Name: | EV MONOCANALICULAR STENT (TM) |
| Classification | Lacrimal Stents And Intubation Sets |
| Applicant | EAGLE VISION, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | Donald L Mackeen |
| Correspondent | Donald L Mackeen EAGLE VISION, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Product Code | OKS |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-01 |
| Decision Date | 1988-08-22 |