510(k) K920604
K920604 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "BIVONA TRACHEAL T-TUBE STENT". The FDA issued a decision of Substantially Equivalent on Jul 27, 1992. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Bivona Medical Technologies has 49 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 27, 1992
- Date Received
- Feb 11, 1992
- 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
- 510(k)