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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 K241622
Device Name Extended Reservoir; MiniMed Reservoir
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact Shruti Prakash
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact Shruti Prakash
Regulation Number880.5725
Classification Product Code
LZG  
Date Received06/05/2024
Decision Date 07/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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