FDA 510(k) Application Details - K130468

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K130468
Device Name	Set, Administration, Intravascular
Applicant	YPSOMED AG BRUNNMATTSTRASSE 6 BURGDORF CH-3401 CH Other 510(k) Applications for this Company
Contact	BENJAMIN REINMANN 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	02/25/2013
Decision Date	03/19/2013
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