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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 K994267
Device Name FRESENIUS 2008K
Applicant
FRESENIUS MEDICAL CARE
TWO LEDGEMONT CENTER
95 HAYDEN AVENUE
LEXINGTON,  MA  02420
Applicant Contact ARTHUR EILINSFELD
Correspondent
FRESENIUS MEDICAL CARE
TWO LEDGEMONT CENTER
95 HAYDEN AVENUE
LEXINGTON,  MA  02420
Correspondent Contact ARTHUR EILINSFELD
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/17/1999
Decision Date 03/16/2000
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
Recalls CDRH Recalls
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