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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 K123835
Device Name 2008 HEMODIALYSIS SORBENT SYSTEM
Applicant
Renal Solutions, Inc.
770 Commonwealth Dr.
Warrendale,  PA  15086
Applicant Contact DAVID VANELLA
Correspondent
Renal Solutions, Inc.
770 Commonwealth Dr.
Warrendale,  PA  15086
Correspondent Contact DAVID VANELLA
Regulation Number876.5600
Classification Product Code
FKT  
Date Received12/13/2012
Decision Date 02/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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