510(k) K042066
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2004
- Date Received
- August 2, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, Traction, Invasive
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type