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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
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