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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, Single Patient
510(k) Number K890824
Device Name FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
Applicant
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Applicant Contact THOMAS E CANE
Correspondent
FRESENIUS USA, INC.
4090 PIKE LN.
CONCORD,  CA  94520
Correspondent Contact THOMAS E CANE
Regulation Number876.5820
Classification Product Code
FKP  
Date Received02/17/1989
Decision Date 05/11/1989
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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