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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K024284
Device Name VICTOREEN THEBES II, MODEL 7020
Applicant
Syncor Radiation Management
6045 Cochran Rd.
Solon,  OH  44139 -3303
Applicant Contact CHRISTINE G CASTLEBERRY
Correspondent
Syncor Radiation Management
6045 Cochran Rd.
Solon,  OH  44139 -3303
Correspondent Contact CHRISTINE G CASTLEBERRY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received12/23/2002
Decision Date 03/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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