FDA 510(k) Application Details - K040899

Device Classification Name Pump, Infusion

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510(K) Number K040899
Device Name Pump, Infusion
Applicant MEDEX, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 40316 US
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Contact BARBARA LAW
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 04/06/2004
Decision Date 04/30/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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