FDA 510(k) Application Details - K060141

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K060141
Device Name	Introducer, Syringe Needle
Applicant	SHL MEDICAL, USA 23 VREELAND RD., SUITE 104 FLORHAM PARK, NJ 07932 US Other 510(k) Applications for this Company
Contact	LUCIO GIAMBATTISTA 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	01/19/2006
Decision Date	06/12/2006
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