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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K020971
Device Name DCM 2.0
Applicant
MDS NORDION AB
447 MARCH ROAD
KANATA, ONTARIO,  CA K2K 1X8
Applicant Contact E. S MARTELL
Correspondent
MDS NORDION AB
447 MARCH ROAD
KANATA, ONTARIO,  CA K2K 1X8
Correspondent Contact E. S MARTELL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/26/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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