510(k) K955455
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1997
- Date Received
- November 29, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Valve
- Device Class
- Class II
- Regulation Number
- 886.3920
- Review Panel
- OP
- Submission Type