FDA 510(k) Application Details - K011117

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K011117
Device Name Pump, Infusion, Elastomeric
Applicant MPS ACACIA
499 NIBUS ST., SUITE E
BREA, CA 92821 US
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Contact FERGIE F FERGUSON
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 04/12/2001
Decision Date 07/09/2001
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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