FDA 510(k) Application Details - K082689

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K082689
Device Name	Saline, Vascular Access Flush
Applicant	SPECTRA MEDICAL DEVICES, INC. 3000 K ST., NW WASHINGTON, DC 20007 US Other 510(k) Applications for this Company
Contact	DAVID L ROSEN 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	09/15/2008
Decision Date	03/20/2009
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