FDA 510(k) Application Details - K090905

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K090905
Device Name Set, I.V. Fluid Transfer
Applicant B. BRAUN MEDICAL, INC.
901 MARCON BLVD.
ALLENTOWN, PA 18109-9341 US
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Contact ANGELA J CARAVELLA
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 04/01/2009
Decision Date 04/27/2009
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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