510(k) K812405
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1981
- Date Received
- August 21, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Surgical And Accessories
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type