FDA 510(k) Application Details - K123084

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K123084
Device Name	Stopcock, I.V. Set
Applicant	ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.N. MEROM HAGALIL 13860 IL Other 510(k) Applications for this Company
Contact	AHARON COHEN Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2012
Decision Date	05/23/2013
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