510(k) K830169
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1983
- Date Received
- January 18, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prism, Gonioscopic
- Device Class
- Class I
- Regulation Number
- 886.1660
- Review Panel
- OP
- Submission Type