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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K062781
Device Name MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
Applicant
Symtium Corporation
11503 Jones Maltsberger
Suite 710
San Antonio,  TX  78216
Applicant Contact SEAN COMER
Correspondent
Symtium Corporation
11503 Jones Maltsberger
Suite 710
San Antonio,  TX  78216
Correspondent Contact SEAN COMER
Regulation Number892.5710
Classification Product Code
IXI  
Date Received09/18/2006
Decision Date 11/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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