510(k) K945745
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1994
- Date Received
- November 23, 1994
- 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