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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hemodialysis system for home use
510(k) Number K124035
Device Name 2008K@HOME HEMODIALYSIS MACHINE
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
920 Winter Street
Waltham,  MA  02451 -1457
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5860
Classification Product Code
ONW  
Subsequent Product Codes
KPO   ODX  
Date Received12/28/2012
Decision Date 07/03/2013
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
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