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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 K060381
Device Name ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
Applicant
RENAL SOLUTIONS, INC.
770 COMMONWEALTH DR.
WARRENDALE,  PA  15086
Applicant Contact DAVID J VANELLA
Correspondent
RENAL SOLUTIONS, INC.
770 COMMONWEALTH DR.
WARRENDALE,  PA  15086
Correspondent Contact DAVID J VANELLA
Regulation Number876.5600
Classification Product Code
FKT  
Date Received02/14/2006
Decision Date 05/24/2006
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
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