FDA 510(k) Application Details - K162219

Device Classification Name	More FDA Info for this Device
510(K) Number	K162219
Device Name	CADD« Infusion Disposables Portfolio with NRFitÖ connectors
Applicant	Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 US Other 510(k) Applications for this Company
Contact	Wendy J. Kivens Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2016
Decision Date	07/20/2017
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