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FDA 510(k) Application Details - K974584
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K974584
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK, CA 94598 US
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VIRGINIA SINGER
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Regulation Number
876.5860
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Classification Product Code
KDI
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Date Received
12/08/1997
Decision Date
05/14/1998
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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