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FDA 510(k) Application Details - K151236
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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