510(k) K192324

Sheridan Spiral-Flex Endotracheal Tubes by Teleflexmedical, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2019
Date Received
August 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type