510(k) K100234
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2010
- Date Received
- January 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type