510(k) K884360
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1988
- Date Received
- October 17, 1988
- 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