510(k) K982962
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1998
- Date Received
- August 24, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Source, Endoscope, Xenon Arc
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type