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FDA 510(k) Application Details - K013733
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
More FDA Info for this Device
510(K) Number
K013733
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
CHF SOLUTIONS, INC.
1730 PENNSYLVANIA AVE., N.W.
WASHINGTON, DC 20006 US
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Contact
DIANNA THOMSEN
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Regulation Number
876.5860
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Classification Product Code
KDI
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More FDA Info for this Product Code
Date Received
11/09/2001
Decision Date
06/03/2002
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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