FDA 510(k) Application Details - K051667

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K051667
Device Name	Introducer, Syringe Needle
Applicant	INDOLOR, LTD. 291 Hillside Avenue Somerset, MA 02726 US Other 510(k) Applications for this Company
Contact	GEORGE J HATTUB 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	06/22/2005
Decision Date	09/27/2005
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