510(k) K902116
K902116 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "MODIFIED ENDOBRONCHIAL TUBE". The FDA issued a decision of Substantially Equivalent on August 3, 1990. The device falls under product code BTS (Tube, Bronchial (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5720. Concord/Portex has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1990
- Date Received
- May 10, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Bronchial (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5720
- Review Panel
- AN
- Submission Type