510(k) K841546
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1984
- Date Received
- April 16, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type