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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 K031099
Device Name SORB+HISORB+CARTRIDGE
Applicant
RENAL SOLUTIONS, INC.
1010 MEADOWVIEW DR.
APOLLO,  PA  15613
Applicant Contact RICHARD G CONFER
Correspondent
RENAL SOLUTIONS, INC.
1010 MEADOWVIEW DR.
APOLLO,  PA  15613
Correspondent Contact RICHARD G CONFER
Regulation Number876.5600
Classification Product Code
FKT  
Date Received04/07/2003
Decision Date 09/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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