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FDA 510(k) Application Details - K970700
Device Classification Name
Hemodialyzer, Re-Use, Low Flux
More FDA Info for this Device
510(K) Number
K970700
Device Name
Hemodialyzer, Re-Use, Low Flux
Applicant
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK, CA 94598 US
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Contact
TOM FOLDEN
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Regulation Number
876.5820
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Classification Product Code
MSE
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More FDA Info for this Product Code
Date Received
02/25/1997
Decision Date
09/15/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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