FDA 510(k) Application Details - K984063

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K984063
Device Name	Set, Administration, Intravascular
Applicant	I-FLOW CORP. 20202 WINDROW DR. LAKE FOREST, CA 92630 US Other 510(k) Applications for this Company
Contact	ROBERT J BARD 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	11/16/1998
Decision Date	02/09/1999
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