FDA 510(k) Application Details - K130405

Device Classification Name	Needle, Emergency Airway   More FDA Info for this Device
510(K) Number	K130405
Device Name	Needle, Emergency Airway
Applicant	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	LORI PFOHL 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	02/19/2013
Decision Date	11/06/2013
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