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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name continuous glucose monitor secondary display
510(k) Number K151236
Device Name MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
Applicant
MEDTRONIC MINIMED, INC.
18000 Devonshire Street
northridge,  CA  91325
Applicant Contact liane r. miller
Correspondent
MEDTRONIC MINIMED, INC.
18000 Devonshire Street
northridge,  CA  91325
Correspondent Contact liane r. miller
Regulation Number862.1350
Classification Product Code
PJT  
Subsequent Product Code
PKU  
Date Received05/11/2015
Decision Date 05/19/2015
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
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