FDA 510(k) Application Details - K003029

Device Classification Name Pump, Infusion

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510(K) Number K003029
Device Name Pump, Infusion
Applicant B. BRAUN MEDICAL, INC.
1601 WALLACE DR., SUITE 150
CARROLLTON, TX 75006 US
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Contact GARY A GULTAS
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 09/28/2000
Decision Date 12/04/2000
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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