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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 K101715
Device Name FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
920 Winter Street
Waltham,  MA  02451 -1457
Applicant Contact RANDOLPH QUINN
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
920 Winter Street
Waltham,  MA  02451 -1457
Correspondent Contact RANDOLPH QUINN
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
KPO  
Date Received06/18/2010
Decision Date 12/21/2010
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
Recalls CDRH Recalls
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