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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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