510(k) K901035
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1990
- Date Received
- March 6, 1990
- Clearance Type
- Traditional
- 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