FDA 510(k) Application Details - K053177

Device Classification Name Pump, Infusion, Insulin

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510(K) Number K053177
Device Name Pump, Infusion, Insulin
Applicant MEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325 US
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Contact STACI ELLIS
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Regulation Number 880.5725

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Classification Product Code LZG
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Date Received 11/14/2005
Decision Date 01/31/2006
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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