510(k) K893731
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1989
- Date Received
- May 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type