The following data is part of a premarket notification filed by Eagle Vision, Inc. with the FDA for Eagle Vision-freeman(tm) Punctal Valve.
| Device ID | K890920 |
| 510k Number | K890920 |
| Device Name: | EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE |
| Classification | Plug, Punctum |
| Applicant | EAGLE VISION, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | L Mackeen,phd |
| Correspondent | L Mackeen,phd 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 | 1989-02-23 |
| Decision Date | 1989-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841668114742 | K890920 | 000 |
| 00841668114667 | K890920 | 000 |
| 00841668114674 | K890920 | 000 |
| 00841668114681 | K890920 | 000 |
| 00841668114698 | K890920 | 000 |
| 00841668114704 | K890920 | 000 |
| 00841668114711 | K890920 | 000 |
| 00841668114728 | K890920 | 000 |
| 00841668114735 | K890920 | 000 |
| 00841668114650 | K890920 | 000 |