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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 K180045
Device Name Omnipod DASH Insulin Management System
Applicant
Insulet Corporation
600 Technology Park Drive
Suite 200
Billerica,  MA  01821
Applicant Contact Matthew King
Correspondent
Insulet Corporation
600 Technology Park Drive
Suite 200
Billerica,  MA  01821
Correspondent Contact Matthew King
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Code
NDC  
Date Received01/08/2018
Decision Date 06/01/2018
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
Recalls CDRH Recalls
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