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FDA 510(k) Application Details - K093362
Device Classification Name
System, Dialysate Delivery, Sorbent Regenerated
More FDA Info for this Device
510(K) Number
K093362
Device Name
System, Dialysate Delivery, Sorbent Regenerated
Applicant
RENAL SOLUTIONS INC.
770 COMMONWEALTH DRIVE
SUITE 101
WARRENDALE, PA 15086 US
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Contact
DAVID J VANELLA
Other 510(k) Applications for this Contact
Regulation Number
876.5600
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Classification Product Code
FKT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2009
Decision Date
08/13/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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