FDA 510(k) Application Details - K022203

Device Classification Name Pump, Infusion, Pca

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510(K) Number K022203
Device Name Pump, Infusion, Pca
Applicant ABBOTT LABORATORIES
DEPT 0389 BLDG J-45
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-6133 US
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Contact FRANK POKROP
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Regulation Number 880.5725

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Classification Product Code MEA
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Date Received 07/05/2002
Decision Date 08/01/2002
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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