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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name alternate controller enabled insulin infusion pump
510(k) Number K191679
Device Name Omnipod DASH Insulin Management System with interoperable technology
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Julie Perkins
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Julie Perkins
Regulation Number880.5730
Classification Product Code
Date Received06/24/2019
Decision Date 09/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No