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FDA 510(k) Application Details - K192756
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K192756
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
CHF Solutions, Inc.
12988 Valley View Road
Eden Prairie, MN 55344 US
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Contact
Dawn Li
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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
09/30/2019
Decision Date
02/24/2020
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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