510(k) K945994
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1995
- Date Received
- November 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Suction, Tracheobronchial
- Device Class
- Class I
- Regulation Number
- 868.6810
- Review Panel
- AN
- Submission Type