510(k) K020889
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2002
- Date Received
- March 19, 2002
- 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