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FDA 510(k) Application Details - K043574
Device Classification Name
System, Dialysate Delivery, Sorbent Regenerated
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510(K) Number
K043574
Device Name
System, Dialysate Delivery, Sorbent Regenerated
Applicant
RENAL SOLUTIONS, INC.
700 COMMONWEALTH DR SUITE 101
WARRENDALE, PA 15086 US
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Contact
RICHARD CONFER
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Regulation Number
876.5600
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Classification Product Code
FKT
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More FDA Info for this Product Code
Date Received
12/27/2004
Decision Date
06/03/2005
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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