510(k) K854052
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1985
- Date Received
- October 3, 1985
- 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