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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: KDI Applicant: FRESENIUS USA, INC. Decision Date To: 05/24/2024
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fresenius modified f400 low volume hemoconcentrator f3000 & modified f400 low vol hemoconcentrator w/tubing set f3000ts FRESENIUS USA, INC. K992275 08/04/1999
fresenius f series hemoconcentrators f400,f500,f700,f800,f400ts,f500ts,f700s,f800ts FRESENIUS USA, INC. K974584 05/14/1998
2008h on line clearance monitor FRESENIUS USA, INC. K961465 07/03/1997
fresenius hemoflow, various models FRESENIUS USA, INC. K926005 08/23/1994
fresenius polysulfone dialyzers FRESENIUS USA, INC. K921134 12/02/1993
fresenius hemoflow, f40m, f50m, f60m & f80m FRESENIUS USA, INC. K892262 04/25/1989
fresenius f8 dialyzer FRESENIUS USA, INC. K883195 09/13/1988
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