FDA 510(k) Application Details - K082837

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K082837
Device Name	Saline, Vascular Access Flush
Applicant	EXCELSIOR MEDICAL CORP. 1933 HECK AVE. NEPTUNE, NJ 07753 US Other 510(k) Applications for this Company
Contact	JOHN LINFANTE Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2008
Decision Date	12/18/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review