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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 K850434
Device Name CS137 SEALED SOURCES
Applicant
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Correspondent Contact ELEANOR V CHIU
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/04/1985
Decision Date 03/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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