FDA 510(k) Application Details - K111467

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K111467
Device Name	Introducer, Syringe Needle
Applicant	ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.N. MEROM HAGALIL 13860 IL Other 510(k) Applications for this Company
Contact	SHAY SHAHAM Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2011
Decision Date	02/09/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review