FDA 510(k) Application Details - K153761

Device Classification Name	Needle, Emergency Airway   More FDA Info for this Device
510(K) Number	K153761
Device Name	Needle, Emergency Airway
Applicant	COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 US Other 510(k) Applications for this Company
Contact	KOTEI AOKI Other 510(k) Applications for this Contact
Regulation Number	868.5090   More FDA Info for this Regulation Number
Classification Product Code	BWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2015
Decision Date	09/22/2016
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