FDA 510(k) Application Details - K020926

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K020926
Device Name	Set, Administration, Intravascular
Applicant	EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK JOHNSTOWN, NY 12095 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER B LAKE 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	03/21/2002
Decision Date	07/12/2002
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