COBE CENTRYSYSTEM CS 200 DIALYZER

Dialyzer, Capillary, Hollow Fiber

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 Cs 200 Dialyzer.

Pre-market Notification Details

Device IDK944436
510k NumberK944436
Device Name:COBE CENTRYSYSTEM CS 200 DIALYZER
ClassificationDialyzer, Capillary, Hollow Fiber
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 CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1996-01-29

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