FDA 510(k) Application Details - K121231

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K121231
Device Name	Saline, Vascular Access Flush
Applicant	IND NDIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BRITISH COLUMBIA V3M 6S7 CA Other 510(k) Applications for this Company
Contact	KAI LOU 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	04/24/2012
Decision Date	07/30/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review