510(k) K140472
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2014
- Date Received
- February 25, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type