FDA 510(k) Application Details - K021293

Device Classification Name	Filter, Infusion Line   More FDA Info for this Device
510(K) Number	K021293
Device Name	Filter, Infusion Line
Applicant	ARTERIA MEDICAL SCIENCE, INC. 22 HILL ST. NEWBURYPORT, MA 01950 US Other 510(k) Applications for this Company
Contact	ALAN HINTON Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2002
Decision Date	08/22/2002
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