FDA 510(k) Application Details - K060759

Device Classification Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K060759
Device Name	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Applicant	ELCAM MEDICAL ACAL KIBUTZ BARAM 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	870.4290   More FDA Info for this Regulation Number
Classification Product Code	DTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2006
Decision Date	06/29/2006
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