510(k) K951292
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1995
- Date Received
- March 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Guide, Intraocular
- Device Class
- Class I
- Regulation Number
- 886.4300
- Review Panel
- OP
- Submission Type