510(k) K051786
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2005
- Date Received
- July 1, 2005
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Fiberoptic
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type