FDA 510(k) Application Details - K113471

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K113471
Device Name	Set, Administration, Intravascular
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	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2011
Decision Date	10/18/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review