FDA 510(k) Application Details - K043235

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K043235
Device Name	Set, Administration, Intravascular
Applicant	DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 ELMHURST, IL 60126 US Other 510(k) Applications for this Company
Contact	JINA YU 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	11/22/2004
Decision Date	03/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review