510(k) K962595
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1996
- Date Received
- July 2, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image, Illumination, Fiberoptic, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type