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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 20 Results
ProductCode: KDI Applicant: GAMBRO RENAL PRODUCTS Decision Date To: 08/09/2022
 
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mars monitor itc us, mars treatment kit type 1116/1 - x-mars us, prismaflex control unit GAMBRO RENAL PRODUCTS, INC. K133807 03/26/2014
prismaflex system 7.10 GAMBRO RENAL PRODUCTS, INC. K131516 01/03/2014
revaclear 300 dialyzer, revaclear 400 dialyzer GAMBRO RENAL PRODUCTS, INC. K130039 05/02/2013
prismaflex GAMBRO RENAL PRODUCTS, INC. K110823 06/17/2011
phoenix hemodialysis delivery system GAMBRO RENAL PRODUCTS, INC. K103832 05/20/2011
prismaflex m150 set GAMBRO RENAL PRODUCTS, INC. K080519 06/13/2008
gambro polyflux hemodialyzer, model: hd-c4 small GAMBRO RENAL PRODUCTS, INC. K072232 09/07/2007
prisma m10 pre set GAMBRO RENAL PRODUCTS, INC. K063183 02/15/2007
prisma system r03.10a GAMBRO RENAL PRODUCTS K062090 10/18/2006
gambro polyflux hd-c4 capillary dialyzer/filter for single use GAMBRO RENAL PRODUCTS K060195 04/24/2006
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