FDA 510(k) Application Details - K091386

Device Classification Name Pump, Infusion

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510(K) Number K091386
Device Name Pump, Infusion
Applicant NUMIA MEDICAL TECHNOLOGY, LLC
230 MAIN ST
LYNDONVILLE, VT 05851 US
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Contact ERIC FLACHBART
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 05/11/2009
Decision Date 10/02/2009
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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