FDA 510(k) Application Details - K043600

Device Classification Name Pump, Infusion

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510(K) Number K043600
Device Name Pump, Infusion
Applicant MEDTRONIC MINIMED
18000 DEVONSHIRE ST.
NORTHRIDGE, CA 91325-1219 US
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Contact GERDA P RESCH
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 12/29/2004
Decision Date 03/29/2005
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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