FDA 510(k) Application Details - K034043

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K034043
Device Name	Catheter, Intravascular, Diagnostic
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	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2003
Decision Date	06/30/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review