GAMBRO HC 14R HEMOCONCENTRATOR

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 Gambro Hc 14r Hemoconcentrator.

Pre-market Notification Details

Device IDK951311
510k NumberK951311
Device Name:GAMBRO HC 14R HEMOCONCENTRATOR
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant COBE RENAL CARE, INC. 1185 OAK ST. Lakewood,  CO  80215 -4407
ContactJeffrey R Shideman
CorrespondentJeffrey R Shideman
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 Received1995-03-22
Decision Date1996-01-11

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