FDA 510(k) Application Details - K082587

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K082587
Device Name	Introducer, Syringe Needle
Applicant	MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD SHEFFIELD S9 2QJ GB Other 510(k) Applications for this Company
Contact	ROSE Y GUANG 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	09/08/2008
Decision Date	10/02/2008
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