COBE CENTRYSYSTEM 14 PES HEMODIALYZERS

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 Cobe Centrysystem 14 Pes Hemodialyzers.

Pre-market Notification Details

Device IDK955592
510k NumberK955592
Device Name:COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant COBE RENAL CARE, INC. 1185 OAK ST. Lakewood,  CO  80215 -4407
ContactJeffrey R Shiderman
CorrespondentJeffrey R Shiderman
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 Received1995-12-07
Decision Date1997-04-30
Summary:summary

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