The following data is part of a premarket notification filed by Tollot Pty.ltd.(aaxis Pacific) with the FDA for Eye Cup, Sterile 1 And Non Sterile.
| Device ID | K051414 |
| 510k Number | K051414 |
| Device Name: | EYE CUP, STERILE 1 AND NON STERILE |
| Classification | Cup, Eye |
| Applicant | TOLLOT PTY.LTD.(AAXIS PACIFIC) 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls TOLLOT PTY.LTD.(AAXIS PACIFIC) 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | LXQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-06-16 |