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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 K003498
Device Name FRESENIUS OPTIFLUX 200A
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02173
Applicant Contact ARTHUR EILINSFELD
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02173
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5860
Classification Product Code
KDI  
Date Received11/13/2000
Decision Date 01/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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