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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Water Purification
510(k) Number K944767
Device Name DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
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 Number876.5665
Classification Product Code
FIP  
Date Received09/27/1994
Decision Date 11/29/1995
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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