FDA 510(k) Application Details - K073538

Device Classification Name Container, I.V.

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510(K) Number K073538
Device Name Container, I.V.
Applicant B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact TRACY MADDOCK
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Regulation Number 880.5025

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Classification Product Code KPE
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Date Received 12/17/2007
Decision Date 03/12/2008
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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