FDA 510(k) Application Details - K030137

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K030137
Device Name	Set, Administration, Intravascular
Applicant	AVAIL MEDICAL PRODUCTS, INC. 8300 ESTERS RD. SUITE 930 IRVING, TX 75063 US Other 510(k) Applications for this Company
Contact	COURTLAND IMEL 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	01/14/2003
Decision Date	02/19/2003
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