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FDA 510(k) Application Details - K060381
Device Classification Name
System, Dialysate Delivery, Sorbent Regenerated
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510(K) Number
K060381
Device Name
System, Dialysate Delivery, Sorbent Regenerated
Applicant
RENAL SOLUTIONS, INC.
770 COMMONWEALTH DR.
WARRENDALE, PA 15086 US
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Contact
DAVID J VANELLA
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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
02/14/2006
Decision Date
05/24/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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