GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0

Irradiator, Blood To Prevent Graft Versus Host Disease

NORDION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Nordion International, Inc. with the FDA for Gammacell 3000 Elan, Version 1.0 And Gammacell 1000 Elite, Version 1.0.

Pre-market Notification Details

Device IDK963497
510k NumberK963497
Device Name:GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
ClassificationIrradiator, Blood To Prevent Graft Versus Host Disease
Applicant NORDION INTERNATIONAL, INC. 447 MARCH RD. P.O. BOX 13500 Kanata, Ontario,  CA K2k1x8
ContactGrant Malkoske
CorrespondentGrant Malkoske
NORDION INTERNATIONAL, INC. 447 MARCH RD. P.O. BOX 13500 Kanata, Ontario,  CA K2k1x8
Product CodeMOT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-03
Decision Date1996-11-08
Summary:summary

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