FDA 510(k) Application Details - K994039

Device Classification Name Pump, Infusion

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510(K) Number K994039
Device Name Pump, Infusion
Applicant ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3537 US
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Contact JERRY JENNINGS
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 11/29/1999
Decision Date 12/22/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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