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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 K921456
Device Name FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
Applicant
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Applicant Contact TOM FOLDEN
Correspondent
FRESENIUS USA, INC.
2637 SHADELANDS DR.
WALNUT CREEK,  CA  94598
Correspondent Contact TOM FOLDEN
Regulation Number876.5820
Classification Product Code
FKP  
Date Received03/27/1992
Decision Date 04/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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