FDA 510(k) Application Details - K141654

Device Classification Name Pump, Infusion

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510(K) Number K141654
Device Name Pump, Infusion
Applicant BELMONT INSTRUMENT CORPORATION
780 BOSTON ROAD
BILLERICA, MA 01821 US
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Contact URAIWAN P LABADINI
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 06/20/2014
Decision Date 07/18/2014
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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