510(k) K902065
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1990
- Date Received
- May 8, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Tracheal Tube
- Device Class
- Class I
- Regulation Number
- 868.5770
- Review Panel
- AN
- Submission Type