FDA 510(k) Applications Submitted by COBE RENAL CARE, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K951311 03/22/1995 GAMBRO HC 14R HEMOCONCENTRATOR COBE RENAL CARE, INC.
K944436 09/12/1994 COBE CENTRYSYSTEM CS 200 DIALYZER COBE RENAL CARE, INC.
K955487 12/01/1995 GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS COBE RENAL CARE, INC.
K955497 12/01/1995 GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET COBE RENAL CARE, INC.
K960474 02/02/1996 COBE CENTRYSYSTEM 600 HG HEMODIALYZERS COBE RENAL CARE, INC.
K955592 12/07/1995 COBE CENTRYSYSTEM 14 PES HEMODIALYZERS COBE RENAL CARE, INC.
K954003 08/25/1995 COBE HEMODYNAMIC RECIRCULATION MONITOR COBE RENAL CARE, INC.
K946279 12/27/1994 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) COBE RENAL CARE, INC.


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