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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 K211575
Device Name Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Dennis Shay
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Dennis Shay
Regulation Number880.5725
Classification Product Code
Subsequent Product Codes
Date Received05/21/2021
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls