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FDA 510(k) Application Details - K191679
Device Classification Name
More FDA Info for this Device
510(K) Number
K191679
Device Name
Omnipod DASH Insulin Management System with interoperable technology
Applicant
Insulet Corporation
100 Nagog Park
Acton, MA 01720 US
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Contact
Julie Perkins
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Regulation Number
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Classification Product Code
QFG
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Date Received
06/24/2019
Decision Date
09/20/2019
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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