FDA 510(k) Application Details - K020189

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K020189
Device Name	Set, Administration, Intravascular
Applicant	EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. LOS ANGELES, CA 90231-3194 US Other 510(k) Applications for this Company
Contact	TAMMIE EWING 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	01/18/2002
Decision Date	03/27/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review