FDA 510(k) Applications Submitted by GAMBRO HEALTHCARE

FDA 510(k) Number Submission Date Device Name Applicant
K970253 01/22/1997 COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET GAMBRO HEALTHCARE
K990039 01/06/1999 GAMBRO DQM 200 GAMBRO HEALTHCARE
K980386 02/02/1998 HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) GAMBRO HEALTHCARE
K982414 07/13/1998 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS GAMBRO HEALTHCARE
K982413 07/13/1998 COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS GAMBRO HEALTHCARE
K982818 08/11/1998 HOSPAL TIPSTOP GAMBRO HEALTHCARE
K994390 12/28/1999 GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER GAMBRO HEALTHCARE
K974899 12/30/1997 GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H GAMBRO HEALTHCARE
K962427 06/24/1996 COBE CENTRYSYSTEM 700 HG HEMODIALYZER GAMBRO HEALTHCARE
K954623 10/05/1995 REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) GAMBRO HEALTHCARE
K981085 03/25/1998 GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM GAMBRO HEALTHCARE
K981681 05/13/1998 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) GAMBRO HEALTHCARE
K982760 08/06/1998 COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET GAMBRO HEALTHCARE


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