FDA 510(k) Application Details - K041318

Device Classification Name Pump, Infusion, Insulin

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510(K) Number K041318
Device Name Pump, Infusion, Insulin
Applicant MEDTRONIC MINIMED
18000 DEVONSHIRE ST.
NORTHRIDGE, CA 91325-1219 US
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Contact MARK J FAILLACE
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Regulation Number 880.5725

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Classification Product Code LZG
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Date Received 05/18/2004
Decision Date 07/19/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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