COBE CENTRYSYSTEM 600 HG 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 600 Hg Hemodialyzers.

Pre-market Notification Details

Device IDK960474
510k NumberK960474
Device Name:COBE CENTRYSYSTEM 600 HG 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 Received1996-02-02
Decision Date1996-08-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.