510(k) K022712
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 2002
- Date Received
- August 14, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drills, Burrs, Trephines & Accessories (Manual)
- Device Class
- Class II
- Regulation Number
- 882.4300
- Review Panel
- NE
- Submission Type