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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 K982926
Device Name FRESENIUS BLOOD VOLUME MONITOR
Applicant
Fresenius Medical Care North America
10 Oak Pt.
Wrentham,  MA  02093
Applicant Contact DONALD A LINCOLN
Correspondent
Fresenius Medical Care North America
10 Oak Pt.
Wrentham,  MA  02093
Correspondent Contact DONALD A LINCOLN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received08/20/1998
Decision Date 09/03/1999
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
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