510(k) K854270
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1985
- Date Received
- October 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Component, Traction, Non-Invasive
- Device Class
- Class I
- Regulation Number
- 888.5890
- Review Panel
- OR
- Submission Type