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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 Pass
510(k) Number K890329
Device Name FRESENIUS 2008 BSS BEDSIDE 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
FIL  
Date Received01/23/1989
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
Predetermined Change
Control Plan Authorized		 No
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