COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO HEALTHCARE

The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing Set.

Pre-market Notification Details

Device IDK982760
510k NumberK982760
Device Name:COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant GAMBRO HEALTHCARE 1185 OAK ST. Lakewood,  CO  80215 -4498
ContactWilliam M Townsend
CorrespondentWilliam M Townsend
GAMBRO HEALTHCARE 1185 OAK ST. Lakewood,  CO  80215 -4498
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-06
Decision Date1998-11-04

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