GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS

Dialyzer, Parallel Flow

COBE RENAL CARE, INC.

The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Gambro Lundia Pro 100, 500, 600 Dialyzers.

Pre-market Notification Details

Device IDK933681
510k NumberK933681
Device Name:GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS
ClassificationDialyzer, Parallel Flow
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 CodeFJG  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-29
Decision Date1994-09-07

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