FDA 510(k) Application Details - K153470

Device Classification Name	Applicator (Laryngo-Tracheal), Topical Anesthesia   More FDA Info for this Device
510(K) Number	K153470
Device Name	Applicator (Laryngo-Tracheal), Topical Anesthesia
Applicant	TELEFLEX MEDICAL 3015 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Kristen Bisanz Other 510(k) Applications for this Contact
Regulation Number	868.5170   More FDA Info for this Regulation Number
Classification Product Code	CCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2015
Decision Date	08/19/2016
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