FDA 510(k) Application Details - K965230

Device Classification Name Pump, Infusion

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510(K) Number K965230
Device Name Pump, Infusion
Applicant ABBOTT MFG., INC.
ONE ABBOTT PARK
ABBOTT PARK, IL 60064 US
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Contact DAVID GUZEK
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 12/31/1996
Decision Date 07/03/1997
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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