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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 K011246
Device Name DCM 1.0
Applicant
Mds Nordion
447 March Rd.
Ottawa,  CA k2k 1x8
Applicant Contact E.S. MARTELL
Correspondent
Mds Nordion
447 March Rd.
Ottawa,  CA k2k 1x8
Correspondent Contact E.S. MARTELL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received04/23/2001
Decision Date 05/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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