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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Separator, Automated, Blood Cell And Plasma, Therapeutic
510(k) Number K050273
FOIA Releasable 510(k) K050273
Device Name FRESENIUS ART HEMOADSORPTION SYSTEM
Applicant
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Applicant Contact JANET KAY
Correspondent
Fresenius Medical Care North America
95 Hayden Ave.
Lexington,  MA  02420
Correspondent Contact JANET KAY
Classification Product Code
LKN  
Date Received02/07/2005
Decision Date 06/08/2005
Decision Substantially Equivalent (SESE)
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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