FDA 510(k) Application Details - K072760

Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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510(K) Number K072760
Device Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Applicant B. BRAUN MEDIZINTECHNOLOGIE GMBH
901 MARCON BOULEVARD
ALLENTOWN, PA 18109-9341 US
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Contact TRACY MADDOCK
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Regulation Number 876.5820

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Classification Product Code KPO
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Date Received 09/28/2007
Decision Date 01/29/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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