510(k) K051522
K051522 is an FDA 510(k) premarket notification submitted by Fuji Systems Corp. for the device "SILBRONCHO DOUBLE LUMEN TUBE". The FDA issued a decision of Substantially Equivalent on Aug 17, 2005. 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. Fuji Systems Corp. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 17, 2005
- Date Received
- Jun 8, 2005
- 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
- 510(k)