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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K922005
Device Name GRANULYTE DIALYSATE CONCENTRATE
Applicant
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Applicant Contact SCOTT N WALKER
Correspondent
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Correspondent Contact SCOTT N WALKER
Regulation Number876.5820
Classification Product Code
KPO  
Date Received04/29/1992
Decision Date 03/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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