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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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More FDA Info for this Product Code
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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