510(k) K142296
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula by
Covidien
— Product Code JOH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2015
- Date Received
- August 18, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube Tracheostomy And Tube Cuff
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type