GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN

Irradiator, Blood To Prevent Graft Versus Host Disease

MDS NORDION

The following data is part of a premarket notification filed by Mds Nordion with the FDA for Gammacell 1000 Elite And Gammacell 3000 Elan.

Pre-market Notification Details

Device IDK050963
510k NumberK050963
Device Name:GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
ClassificationIrradiator, Blood To Prevent Graft Versus Host Disease
Applicant MDS NORDION 447 MARCH RD. Ottawa, Ontario,  CA K2k1x8
ContactRoss Kachaniwsky
CorrespondentRoss Kachaniwsky
MDS NORDION 447 MARCH RD. Ottawa, Ontario,  CA K2k1x8
Product CodeMOT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-18
Decision Date2005-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00754014600021 K050963 000
00754014600014 K050963 000
07540146000029 K050963 000
07540146000012 K050963 000

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