FDA 510(k) Application Details - K032075

Device Classification Name Solution-Test Standard-Conductivity, Dialysis

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510(K) Number K032075
Device Name Solution-Test Standard-Conductivity, Dialysis
Applicant IBP INSTRUMENTS GMBH
SUTELSTRASSE 7A
HANNOVER D30659 DE
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Contact WERNER PFINGSTMANN
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Regulation Number 876.5820

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Classification Product Code FKH
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Date Received 07/07/2003
Decision Date 09/17/2003
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 Y
Expedited Review



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