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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 K192659
Device Name Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Applicant
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Julie Perkins
Correspondent
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Julie Perkins
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Codes
NBW   NDC  
Date Received09/25/2019
Decision Date 10/21/2019
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
Recalls CDRH Recalls
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