510(k) K973756
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1997
- Date Received
- October 2, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Keratoscope, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type