FDA 510(k) Application Details - K032642

Device Classification Name Pump, Infusion

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510(K) Number K032642
Device Name Pump, Infusion
Applicant MCKINLEY, INC.
4080 YOUNGFIELD ST.
WHEAT RIDGE, CO 80033 US
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Contact ANDY LAMBORNE
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 08/27/2003
Decision Date 09/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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