FDA 510(k) Application Details - K163357

Device Classification Name	Pump, Infusion, Insulin Bolus   More FDA Info for this Device
510(K) Number	K163357
Device Name	Pump, Infusion, Insulin Bolus
Applicant	LifeScan Europe, a division of Cilag GmbH Gubelstrasse 34 Zug CH-6300 CH Other 510(k) Applications for this Company
Contact	Kirsten Franco Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	OPP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2016
Decision Date	06/07/2017
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