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FDA 510(k) Application Details - K031099
Device Classification Name
System, Dialysate Delivery, Sorbent Regenerated
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510(K) Number
K031099
Device Name
System, Dialysate Delivery, Sorbent Regenerated
Applicant
RENAL SOLUTIONS, INC.
1010 MEADOWVIEW DR.
APOLLO, PA 15613 US
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Contact
RICHARD G CONFER
Other 510(k) Applications for this Contact
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
04/07/2003
Decision Date
09/17/2003
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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