FDA 510(k) Application Details - K011442

Device Classification Name Pump, Infusion

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510(K) Number K011442
Device Name Pump, Infusion
Applicant ABBOTT LABORATORIES
DEPT 37K BLDG AP30
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064 US
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Contact FRANK POKROP
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 05/10/2001
Decision Date 06/05/2001
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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