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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin Bolus
510(k) Number K163357
Device Name OneTouch Via On-Demand Insulin Delivery System
Applicant
Lifescan Europe, A Division of Cilag GmbH
Gubelstrasse 34
Zug,  CH Ch-6300
Applicant Contact Kirsten Franco
Correspondent
Lifescan, Inc.
965 Chesterbrook Blvd.
Wayne,  PA  19087
Correspondent Contact Kirsten Franco
Regulation Number880.5725
Classification Product Code
OPP  
Subsequent Product Code
LZG  
Date Received11/30/2016
Decision Date 06/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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