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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 K992275
Device Name FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
Applicant
Fresenius USA, Inc.
110 Mason Cr
Concord,  CA 
Applicant Contact VIRGINIA SINGER
Correspondent
Fresenius USA, Inc.
110 Mason Cr
Concord,  CA 
Correspondent Contact VIRGINIA SINGER
Regulation Number876.5860
Classification Product Code
KDI  
Date Received07/07/1999
Decision Date 08/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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