FDA 510(k) Application Details - K151236

Device Classification Name

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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 US
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Contact Liane R. Miller
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Regulation Number

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Classification Product Code PJT
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Date Received 05/11/2015
Decision Date 05/19/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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