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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 12 Results
ProductCode: KPO Applicant: FRESENIUS MEDICAL CARE Decision Date To: 12/07/2021
 
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citrasate dry acid concentrate, granuflo dry acid concentrate Fresenius Medical Care Renal Therapies Group, LLC K192209 05/08/2020
citrasate liquid acid concentrate, naturalyte liquid acid concentrate Fresenius Medical Care Renal Therapies Group, LLC K192017 04/24/2020
naturalyte dry bicarbonate concentrate (rx-10 bag), naturalyte dry bicarbonate concentrate (rx-12 bag), naturalyte dry bicarbonate concentrate (carton) Fresenius Medical Care Renal Therapies Group, LLC K191474 02/24/2020
bibag FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC K162716 05/18/2017
fresenius dry acid dissolution units FRESENIUS MEDICAL CARE NORTH AMERICA K131611 08/29/2013
2008k@home hemodialysis machine FRESENIUS MEDICAL CARE NORTH AMERICA K124035 07/03/2013
fresenius 2008t hemodialysis machine with bibag system FRESENIUS MEDICAL CARE, NORTH AMERICA K121341 12/06/2012
fresenius 2008 hemodiaysis machine with bibag system FRESENIUS MEDICAL CARE, NORTH AMERICA K120017 02/02/2012
fresenius 2008t hemodialysis machine model 190573 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE K101715 12/21/2010
fresenius naturalyte sodium bicarbonate liquid concentrate, model 08-4000-lb FRESENIUS MEDICAL CARE NORTH AMERICA K071387 06/15/2007
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