FDA 510(k) Application Details - K013362

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K013362
Device Name	Introducer, Syringe Needle
Applicant	OWEN MUMFORD USA, INC. 1755-A WEST OAK COMMONS CT. MARIETTA, GA 30062 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	10/10/2001
Decision Date	11/13/2001
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