510(k) K152952
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2016
- Date Received
- October 6, 2015
- Clearance Type
- Traditional
- 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