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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 K043244
Device Name FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420 -9192
Applicant Contact ARTHUR EILINSFELD
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420 -9192
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
FJI  
Date Received11/23/2004
Decision Date 12/20/2004
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
Recalls CDRH Recalls
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