FDA 510(k) Application Details - K052451

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K052451
Device Name Pump, Infusion, Elastomeric
Applicant MPS ACACIA
785 CHALLENGER ST.
BREA, CA 92821 US
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Contact FERGIE FERGUSON
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 09/07/2005
Decision Date 12/08/2005
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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