510(k) K160297
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2016
- Date Received
- February 3, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type