510(k) K831788
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1983
- Date Received
- June 3, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sigmoidoscope, Rigid, Electrical
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type