510(k) K151575
K151575 is an FDA 510(k) premarket notification submitted by Dynarex Corporation for the device "Dynarex Eye Cups". The FDA issued a decision of Substantially Equivalent on September 1, 2015. The device falls under product code LXQ (Cup, Eye), a Class U device. Dynarex Corporation has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2015
- Date Received
- June 11, 2015
- 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