FDA 510(k) Application Details - K111034

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K111034
Device Name	Saline, Vascular Access Flush
Applicant	AM USA 5209 LINDBAR DRIVE SUITE 640 NASHVILLE, TN 37167 US Other 510(k) Applications for this Company
Contact	KAREN THOMISON 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	04/13/2011
Decision Date	07/14/2011
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