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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 K070739
Device Name ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
Applicant
Renal Solutions, Inc.
770 Commonwealth Dr. Suite 101
Warrendale,  PA  15086
Applicant Contact DAVID J VANELLA
Correspondent
Renal Solutions, Inc.
770 Commonwealth Dr. Suite 101
Warrendale,  PA  15086
Correspondent Contact DAVID J VANELLA
Regulation Number876.5600
Classification Product Code
FKT  
Date Received03/16/2007
Decision Date 05/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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