FDA 510(k) Application Details - K251032

Device Classification Name

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510(K) Number K251032
Device Name MiniMed 780G insulin pump
Applicant Medtronic MiniMed Inc.
18000 Devonshire Street
Northridge, CA 91325 US
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Contact Hemang Kotecha
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Regulation Number

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Classification Product Code QFG
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Date Received 04/03/2025
Decision Date 07/01/2025
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

FDA Source Information for K251032


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