510(k) K082038
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2009
- Date Received
- July 17, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type