510(k) K945350
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1994
- Date Received
- September 14, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Frame, Spectacle
- Device Class
- Class I
- Regulation Number
- 886.5842
- Review Panel
- OP
- Submission Type