FDA 510(k) Application Details - K032848

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K032848
Device Name	Introducer, Syringe Needle
Applicant	MEDSOLVE TECHNOLOGIES LLC 4635 GERSHWIN PLACE WOODLAND HILLS, CA 91364 US Other 510(k) Applications for this Company
Contact	SUSAN MCCONNELL 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	09/12/2003
Decision Date	04/12/2004
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