FDA 510(k) Application Details - K142596

Device Classification Name Pump, Infusion

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510(K) Number K142596
Device Name Pump, Infusion
Applicant B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109 US
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Contact Gary Johnson
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 09/15/2014
Decision Date 06/18/2015
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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