FDA 510(k) Application Details - K121262

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K121262
Device Name	Saline, Vascular Access Flush
Applicant	MEDEFIL, INC. 250 WINDY POINT DR. GLENDALE HEIGHTS, IL 60139 US Other 510(k) Applications for this Company
Contact	PRADEEP AGGARWAL 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	04/26/2012
Decision Date	09/20/2012
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