FDA 510(k) Application Details - K180253

Device Classification Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K180253
Device Name	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Applicant	Teleflex Medical 3015 Carrington Mills Blvd Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Lori Pfohl Other 510(k) Applications for this Contact
Regulation Number	868.5740   More FDA Info for this Regulation Number
Classification Product Code	CBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/2018
Decision Date	11/02/2018
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