FDA 510(k) Application Details - K112628

Device Classification Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve   More FDA Info for this Device
510(K) Number	K112628
Device Name	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant	NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. MIAMI, FL 33172 US Other 510(k) Applications for this Company
Contact	JESSICA OSWALD Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2011
Decision Date	09/28/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review