FDA 510(k) Application Details - K150513

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K150513
Device Name	Set, Administration, Intravascular
Applicant	IMED TECHNOLOGY, INC. 2544 TARPLEY RD. STE 112 CARROLLTON, TX 75006 US Other 510(k) Applications for this Company
Contact	KYLE ADAMS 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	02/27/2015
Decision Date	05/28/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review