510(k) K063304
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2007
- Date Received
- November 1, 2006
- Clearance Type
- Traditional
- 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