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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
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