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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
510(k) Number K162296
Device Name OmniPod Insulin Management System
Applicant
Insulet Corporation
600 Technology Park Dr.
Suite 200
Billerica,  MA  01821
Applicant Contact MATTHEW KING
Correspondent
Insulet Corporation
600 Technology Park Dr.
Suite 200
Billerica,  MA  01821
Correspondent Contact MATTHEW KING
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Codes
NBW   NDC  
Date Received08/16/2016
Decision Date 04/18/2017
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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