FDA 510(k) Application Details - K173913

Device Classification Name	More FDA Info for this Device
510(K) Number	K173913
Device Name	MEDRAD« Imaging Bulk Package Transfer Set
Applicant	Bayer U.S. LLC 1 Bayer Drive Indianola, PA 15051 US Other 510(k) Applications for this Company
Contact	Leslie S. O'Nan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2017
Decision Date	05/04/2018
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