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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 19 of 19 Results
ProductCode: KDI Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA Decision Date To: 08/10/2022
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fresenius renal acute care (rac 100) filter, model 0500610n FRESENIUS MEDICAL CARE NORTH AMERICA K070222 04/24/2007
fresenius ultraflo hpx hemodialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K034064 01/30/2004
fresenius ultraflux hemodialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K031378 05/30/2003
fresnius hemoflow f7nr, f50nr, f70nr hemodialyzers FRESENIUS MEDICAL CARE NORTH AMERICA K002761 12/04/2000
modification to:fresenius 2008t hemodialysis machine, model 190573 FRESENIUS MEDICAL CARE NORTH AMERICA K093902 05/27/2010
optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K152367 10/29/2015
optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K162488 04/06/2017
optiflux f250nr, model 0500325e FRESENIUS MEDICAL CARE NORTH AMERICA K082414 10/28/2008
optiflux ultra dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA K123262 01/06/2014
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