FDA 510(k) Application Details - K192324

Device Classification Name	Tube, Tracheal (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K192324
Device Name	Tube, Tracheal (W/Wo Connector)
Applicant	TeleflexMedical, Inc 3015 Carrington Mill Blvd , Suite 600 North Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Lori Pfohl Other 510(k) Applications for this Contact
Regulation Number	868.5730   More FDA Info for this Regulation Number
Classification Product Code	BTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2019
Decision Date	12/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review