FDA 510(k) Application Details - K140984

Device Classification Name	Tank, Holding, Dialysis   More FDA Info for this Device
510(K) Number	K140984
Device Name	Tank, Holding, Dialysis
Applicant	TANGO3, LLC 141 CITIZENS BLVD SIMPSONVILLE, KY 40067 US Other 510(k) Applications for this Company
Contact	LORI HOLDER Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2014
Decision Date	01/12/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review