GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Fiber Hemofilters Fh 22/66 Dispos Tube Sets.

Pre-market Notification Details

Device IDK860938
510k NumberK860938
Device Name:GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
ContactJeffrey R Shideman
CorrespondentJeffrey R Shideman
GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-12
Decision Date1986-04-07

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