510(k) K973290
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1997
- Date Received
- September 2, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoilluminator
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- OP
- Submission Type