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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 K150708
Device Name 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
Applicant
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
920 Winter Street
Waltham,  MA  02451
Applicant Contact DENISE OPPERMANN
Correspondent
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
920 Winter Street
Waltham,  MA  02451
Correspondent Contact DENISE OPPERMANN
Regulation Number876.5860
Classification Product Code
KDI  
Subsequent Product Code
ONW  
Date Received03/19/2015
Decision Date 12/10/2015
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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