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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, proportioning
510(k) Number K850435
Device Name SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
Applicant
SARTORIUS FILTERS, INC.
26575 CORPORATE AVE.
HAYWARD,  CA  94545
Applicant Contact STEVEN CATES
Correspondent
SARTORIUS FILTERS, INC.
26575 CORPORATE AVE.
HAYWARD,  CA  94545
Correspondent Contact STEVEN CATES
Regulation Number876.5820
Classification Product Code
FKR  
Date Received02/04/1985
Decision Date 06/04/1985
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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