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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 K973328
Device Name INTERSOURCE
Applicant
International Brachytherapy S.A.
Zone Industrielle C
7180 Seneffe,  BE 7180
Applicant Contact VINCENT E CONIGLIONE
Correspondent
International Brachytherapy S.A.
Zone Industrielle C
7180 Seneffe,  BE 7180
Correspondent Contact VINCENT E CONIGLIONE
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/04/1997
Decision Date 12/10/1998
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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