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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, High Permeability With Or Without Sealed Dialysate System
510(k) Number K974584
Device Name FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS
Applicant
Fresenius USA, Inc.
2637 Shadelands Dr.
Walnut Creek,  CA  94598
Applicant Contact VIRGINIA SINGER
Correspondent
Fresenius USA, Inc.
2637 Shadelands Dr.
Walnut Creek,  CA  94598
Correspondent Contact VIRGINIA SINGER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/08/1997
Decision Date 05/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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