510(k) K091591
K091591 is an FDA 510(k) premarket notification submitted by Flexicare Medical, Ltd. for the device "FLEXICARE MEDICAL ENDOTRACHEAL TUBES". The FDA issued a decision of Substantially Equivalent on June 17, 2009. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Flexicare Medical, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2009
- Date Received
- June 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Tube, Tracheal (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5730
- Review Panel
- AN
- Submission Type