510(k) K143164
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2014
- Date Received
- November 3, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- AN
- Submission Type