FDA 510(k) Application Details - K000482

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K000482
Device Name	Introducer, Syringe Needle
Applicant	OWEN MUMFORD, LTD. 849 PICKENS INDUSTRIAL DR. SUITE 14 MARIETTA, GA 30062-3165 US Other 510(k) Applications for this Company
Contact	ROBERT SHAW 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	02/14/2000
Decision Date	03/06/2000
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