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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 K034064
Device Name FRESENIUS ULTRAFLO HPX HEMODIALYZER
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  
Date Received12/31/2003
Decision Date 01/30/2004
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
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