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FDA 510(k) Application Details - K121497
Device Classification Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
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510(K) Number
K121497
Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant
RENAL SOLUTIONS INC.
770 COMMONWEALTH DRIVE
SUITE 101
WARRENDALE, PA 15086 US
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DAVID VANELLA
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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
05/21/2012
Decision Date
08/17/2012
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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