510(k) K051414
K051414 is an FDA 510(k) premarket notification submitted by Tollot Pty.Ltd.(Aaxis Pacific) for the device "EYE CUP, STERILE 1 AND NON STERILE". The FDA issued a decision of Substantially Equivalent on June 16, 2005. The device falls under product code LXQ (Cup, Eye), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2005
- Date Received
- May 31, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Eye
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type