510(k) K913626
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1991
- Date Received
- August 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraocular Lens
- Device Class
- Class III
- Regulation Number
- 886.3600
- Review Panel
- OP
- Submission Type