510(k) K820626
K820626 is an FDA 510(k) premarket notification submitted by Video-Medical Devices, Ltd. for the device "OPTI-DISC". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code KQM (Camera, Surgical And Accessories), a Class I device regulated under 21 CFR 878.4160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1982
- Date Received
- March 8, 1982
- 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