FDA 510(k) Application Details - K060339

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K060339
Device Name	Saline, Vascular Access Flush
Applicant	TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	BRIDGET GARDNER 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	02/10/2006
Decision Date	04/28/2006
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