FDA 510(k) Applications Submitted by THOMAS B DOWELL

FDA 510(k) Number Submission Date Device Name Applicant
K060195 01/25/2006 GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE GAMBRO RENAL PRODUCTS
K040301 02/09/2004 GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A GAMBRO RENAL PRODUCTS
K070414 02/12/2007 GAMBRO CARTRIDGE BLOOD SETS GAMBRO RENAL PRODUCTS
K070643 03/08/2007 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 GAMBRO, INC.
K041005 04/19/2004 GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS GAMBRO RENAL PRODUCTS
K051520 06/08/2005 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H GAMBRO RENAL PRODUCTS
K062090 07/24/2006 PRISMA SYSTEM R03.10A GAMBRO RENAL PRODUCTS
K072093 07/30/2007 PRISMAFLEX SYSTEM, VERSION 3.20 GAMBRO
K042938 10/25/2004 GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS GAMBRO RENAL PRODUCTS
K063290 11/01/2006 GAMBRO QUICKSET BLOODLINES GAMBRO RENAL PRODUCTS


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