HEMOFILTRATION SYSTEM 10

System, Dialysate Delivery, Sealed

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Hemofiltration System 10.

Pre-market Notification Details

Device IDK862716
510k NumberK862716
Device Name:HEMOFILTRATION SYSTEM 10
ClassificationSystem, Dialysate Delivery, Sealed
Applicant GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
ContactJeffrey Shideman
CorrespondentJeffrey Shideman
GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
Product CodeFII  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-17
Decision Date1986-09-09

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