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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 K093902
Device Name MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Applicant Contact RANDOLPH QUINN
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Correspondent Contact RANDOLPH QUINN
Regulation Number876.5860
Classification Product Code
KDI  
Date Received12/22/2009
Decision Date 05/27/2010
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
Recalls CDRH Recalls
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