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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 13 Results
ProductCode: KPO Applicant: FRESENIUS MEDICAL CARE Decision Date To: 08/07/2022
 
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2008k@home hemodialysis machine FRESENIUS MEDICAL CARE NORTH AMERICA K124035 07/03/2013
bibag FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC K162716 05/18/2017
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
citrasate liquid acid concentrate, naturalyte liquid acid concentrate Fresenius Medical Care Renal Therapies Group, LLC K212620 05/12/2022
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 2008t hemodialysis machine with bibag system FRESENIUS MEDICAL CARE, NORTH AMERICA K121341 12/06/2012
fresenius dry acid dissolution units FRESENIUS MEDICAL CARE NORTH AMERICA K131611 08/29/2013
fresenius naturalyte granuflo dry acid concentrate 10xx series, 24xx series, 30xx series FRESENIUS MEDICAL CARE K030497 05/20/2003
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