510(k) K862517
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1986
- Date Received
- July 1, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Measuring, Lens Radius, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1430
- Review Panel
- OP
- Submission Type