FDA 510(k) Application Details - K033696

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K033696
Device Name	Introducer, Syringe Needle
Applicant	UNION MEDICO APS EMDRUPVEJ 22 COPENHAGEN 2100 DK Other 510(k) Applications for this Company
Contact	MICHAEL PERTHU Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2003
Decision Date	02/16/2005
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