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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irradiator, Blood To Prevent Graft Versus Host Disease
510(k) Number K952291
Device Name GAMMACELL 3000 ELAN
Applicant
Nordion International, Inc.
1800 M St. NW
Washington,  DC  20036
Applicant Contact KATHRYN L GLEASON
Correspondent
Nordion International, Inc.
1800 M St. NW
Washington,  DC  20036
Correspondent Contact KATHRYN L GLEASON
Classification Product Code
MOT  
Date Received05/16/1995
Decision Date 08/25/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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