FDA 510(k) Application Details - K173531

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K173531
Device Name	Accessories, Pump, Infusion
Applicant	B. Braun Medical Inc. 901 Marcon Blvd Allentown, PA 18109 US Other 510(k) Applications for this Company
Contact	Tracy Maddock Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2017
Decision Date	08/02/2018
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