510(k) K860955
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1986
- Date Received
- March 13, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Spectacle, Non-Custom (Prescription)
- Device Class
- Class I
- Regulation Number
- 886.5844
- Review Panel
- OP
- Submission Type