FDA 510(k) Application Details - K030531

Device Classification Name Pump, Infusion, Insulin

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510(K) Number K030531
Device Name Pump, Infusion, Insulin
Applicant MINIMED, INC.
18000 DEVONSHIRE ST.
NORTHRIDGE, CA 91325 US
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Contact GERDA P RESCH
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Regulation Number 880.5725

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Classification Product Code LZG
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Date Received 02/19/2003
Decision Date 06/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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