FDA 510(k) Application Details - K981816

Device Classification Name Pump, Infusion

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510(K) Number K981816
Device Name Pump, Infusion
Applicant BECTON DICKINSON CURLIN, LLC.
15751 GRAHAM ST.
HUNTINGTON BEACH, CA 92649 US
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Contact CHARLES J WELLE
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 05/22/1998
Decision Date 12/04/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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