510(k) K192282
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2020
- Date Received
- August 22, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Driver, Wire, And Bone Drill, Manual
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type