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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 K080964
Device Name FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Applicant Contact JANET C KAY
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Correspondent Contact JANET C KAY
Regulation Number876.5860
Classification Product Code
KDI  
Date Received04/04/2008
Decision Date 01/14/2009
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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