FDA 510(k) Application Details - K162729

Device Classification Name	Stylet, Tracheal Tube   More FDA Info for this Device
510(K) Number	K162729
Device Name	Stylet, Tracheal Tube
Applicant	COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	KOTEI AOKI Other 510(k) Applications for this Contact
Regulation Number	868.5790   More FDA Info for this Regulation Number
Classification Product Code	BSR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2016
Decision Date	08/11/2017
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