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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, dialysate delivery, sorbent regenerated
510(k) Number K093362
Device Name 2008 HEMODIALYSIS SORBENT SYSTEM
Applicant
RENAL SOLUTIONS INC.
770 COMMONWEALTH DRIVE
SUITE 101
WARRENDALE,  PA  15086
Applicant Contact DAVID J VANELLA
Correspondent
RENAL SOLUTIONS INC.
770 COMMONWEALTH DRIVE
SUITE 101
WARRENDALE,  PA  15086
Correspondent Contact DAVID J VANELLA
Regulation Number876.5600
Classification Product Code
FKT  
Date Received10/28/2009
Decision Date 08/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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