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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 K121341
Device Name FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
Applicant
FRESENIUS MEDICAL CARE, NORTH AMERICA
920 WINTER STREET
WALTHAM,  MA  01854
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE, NORTH AMERICA
920 WINTER STREET
WALTHAM,  MA  01854
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
KPO  
Date Received05/03/2012
Decision Date 12/06/2012
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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