FDA 510(k) Application Details - K042547

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K042547
Device Name	Syringe, Piston
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	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2004
Decision Date	12/01/2004
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