FDA 510(k) Application Details - K952799

Device Classification Name Pump, Infusion

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510(K) Number K952799
Device Name Pump, Infusion
Applicant ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
D389, AP30
ABBOTT PARK, IL 60064 US
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Contact DAVID T GUZEK
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 06/19/1995
Decision Date 01/18/1996
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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