FDA 510(k) Application Details - K082106

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K082106
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	TALI HAZAN 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	07/25/2008
Decision Date	10/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review