FDA 510(k) Application Details - K060389

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K060389
Device Name	Introducer, Syringe Needle
Applicant	PHARMA-PEN, INC. 555 13TH STREET, NW WASHINGTON, DC 20004-1109 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHN 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	02/14/2006
Decision Date	06/06/2006
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