510(k) K092886
K092886 is an FDA 510(k) premarket notification submitted by Well Lead Instruments for the device "WELL LEAD ENDOBRONCHIAL TUBES". The FDA issued a decision of Substantially Equivalent on March 11, 2010. The device falls under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2010
- Date Received
- September 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5740
- Review Panel
- AN
- Submission Type