510(k) K941342
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1995
- Date Received
- February 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Spinal-Cord, Implanted (Pain Relief)
- Device Class
- Class II
- Regulation Number
- 882.5880
- Review Panel
- NE
- Submission Type