FDA 510(k) Application Details - K141306

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K141306
Device Name	Set, Administration, Intravascular
Applicant	TEVA MEDICAL LTD., MIGADA PLANT PIAZZA ALBANIA 10 ROME 00153 IT Other 510(k) Applications for this Company
Contact	ROGER GRAY 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	05/19/2014
Decision Date	06/12/2014
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