510(k) K012265
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2001
- Date Received
- July 19, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Source, Fiberoptic, Routine
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type