FDA 510(k) Application Details - K112799

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K112799
Device Name	Set, Administration, Intravascular
Applicant	BENLAN INC 2760 BRIGHTON RD OAKVILLE L6H 5T4 CA Other 510(k) Applications for this Company
Contact	CHERYL BROWN Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2011
Decision Date	12/23/2011
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