Eye Cup, Sterile 1 and Non Sterile
FDA 510(k) K051414 · Tollot Pty.Ltd.(Aaxis Pacific)
510(k) numberK051414
Submission
- Device name
- Eye Cup, Sterile 1 and Non Sterile
- Applicant
- Tollot Pty.Ltd.(Aaxis Pacific)
Littleton, CO, US - Received
- May 31, 2005
- Decision date
- June 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LXQ – Cup, Eye
- Device class
- Unclassified
Other 510(k)s with product code LXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151575 | Dynarex Eye CupsLXQ · Traditional | Dynarex Corporation | 09/01/2015SE |
| K140409 | Flents Plastic Eye Wash CupLXQ · Traditional | Apothecary Products, Inc. | 07/09/2014SE |
| K971134 | Vista EyeshowerLXQ · Traditional | John Branch | 11/04/1997SE |
| K881369 | Advance Diagnostics Disposable EyecupLXQ · Traditional | Advantage Diagnostics Corp. | 05/13/1988SE |
Questions and answers
When was Eye Cup, Sterile 1 and Non Sterile cleared by the FDA?
Eye Cup, Sterile 1 and Non Sterile (K051414) received a 510(k) decision of Substantially Equivalent on June 16, 2005, 16 days after the submission was received.
What is the product code of K051414?
The FDA product code is LXQ – Cup, Eye, a Unclassified device.