FDA 510(k) Application Details - K233713

Device Classification Name	Tube, Tracheostomy (W/Wo Connector)   More FDA Info for this Device
510(K) Number	K233713
Device Name	Tube, Tracheostomy (W/Wo Connector)
Applicant	Teleflex Medical 3015 Carrington Mill Blvd. Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Hannah Boning Other 510(k) Applications for this Contact
Regulation Number	868.5800   More FDA Info for this Regulation Number
Classification Product Code	BTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2023
Decision Date	03/22/2024
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