FDA 510(k) Application Details - K073444

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K073444
Device Name	Set, Administration, Intravascular
Applicant	TRITON MEDICAL, LLC 1705 S. CAPITAL OF TEXAS HWY AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	IAN P GORDON 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	12/07/2007
Decision Date	08/18/2008
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