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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 44 Results
ProductCode: KDI Applicant: GAMBRO Decision Date To: 08/19/2022
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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
exalis, software version 1.15 GAMBRO, INC. K083158 06/05/2009
prismaflex m150 set GAMBRO RENAL PRODUCTS, INC. K080519 06/13/2008
prismaflex system, version 3.20 GAMBRO K072093 02/01/2008
phoenix hemodialysis delivery system, version 3.35 GAMBRO, INC. K070643 11/02/2007
gambro polyflux hemodialyzer, model: hd-c4 small GAMBRO RENAL PRODUCTS, INC. K072232 09/07/2007