510(k) K923725
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1993
- Date Received
- July 27, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type