510(k) K063617
K063617 is an FDA 510(k) premarket notification submitted by Al.Chi.Mi.A for the device "EUSOL-C". The FDA issued a decision of Substantially Equivalent on February 8, 2007. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Al.Chi.Mi.A has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2007
- Date Received
- December 5, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Corneal Storage
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type