FDA 510(k) Application Details - K010824

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K010824
Device Name Pump, Infusion, Elastomeric
Applicant SCIENCE INCORPORATED
MINNESOTA CENTER, SUITE 1060
7760 FRANCE AVENUE SOUTH
BLOOMINGTON, MN 55435-5803 US
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Contact LYNN S WEIST
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 03/19/2001
Decision Date 06/05/2001
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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