510(k) K023633
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 2002
- Date Received
- October 29, 2002
- 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