PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)

Dialyzer, High Permeability With Or Without Sealed Dialysate System

COBE RENAL CARE, INC.

The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Prisma Cfm (continuous Fluid Management System).

Pre-market Notification Details

Device IDK946279
510k NumberK946279
Device Name:PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant COBE RENAL CARE, INC. 1185 OAK ST. Lakewood,  CO  80215 -4407
ContactMatthew M Hull
CorrespondentMatthew M Hull
COBE RENAL CARE, INC. 1185 OAK ST. Lakewood,  CO  80215 -4407
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-27
Decision Date1997-02-10

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