FDA 510(k) Application Details - K040114

Device Classification Name Pump, Infusion

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510(K) Number K040114
Device Name Pump, Infusion
Applicant ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-6157 US
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Contact PATRICIA MELERSKI
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 01/20/2004
Decision Date 01/29/2004
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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