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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 K153449
Device Name 2008K2 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  
Date Received11/30/2015
Decision Date 04/26/2016
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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