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FDA 510(k) Application Details - K241622
Device Classification Name
Pump, Infusion, Insulin
More FDA Info for this Device
510(K) Number
K241622
Device Name
Pump, Infusion, Insulin
Applicant
Medtronic MiniMed
18000 Devonshire St
Northridge, CA 91325 US
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Contact
Shruti Prakash
Other 510(k) Applications for this Contact
Regulation Number
880.5725
More FDA Info for this Regulation Number
Classification Product Code
LZG
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More FDA Info for this Product Code
Date Received
06/05/2024
Decision Date
07/02/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241622
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