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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K030745
Device Name GAMMAMED 212 AND 232 SOURCE ASSEMBLY
Applicant
Varian Medical Systems
700 Harris St.
Suite 109
Charlottesville,  VA  22903 -1038
Applicant Contact VY TRAN
Correspondent
Varian Medical Systems
700 Harris St.
Suite 109
Charlottesville,  VA  22903 -1038
Correspondent Contact VY TRAN
Regulation Number892.5730
Classification Product Code
KXK  
Date Received03/10/2003
Decision Date 03/12/2003
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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