510(k) K883857
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1988
- Date Received
- September 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Fiberoptic, Surgical Field
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type