GAMBRO PLASMAFILTRATION SYSTEM

Separator, Automated, Blood Cell And Plasma, Therapeutic

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Plasmafiltration System.

Pre-market Notification Details

Device IDK850621
510k NumberK850621
Device Name:GAMBRO PLASMAFILTRATION SYSTEM
ClassificationSeparator, Automated, Blood Cell And Plasma, Therapeutic
Applicant GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
ContactJeffrey R Shideman
CorrespondentJeffrey R Shideman
GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
Product CodeLKN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-15
Decision Date1985-05-16

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