FDA 510(k) Application Details - K061497

Device Classification Name	Heparin, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K061497
Device Name	Heparin, Vascular Access Flush
Applicant	EXCELSIOR MEDICAL CORP. 1933 HECK AVE NEPTUNE, NJ 07753 US Other 510(k) Applications for this Company
Contact	JOHN TALARICO Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NZW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2006
Decision Date	02/23/2007
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