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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 K932242
Device Name RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345
Applicant
Best Industries
7643 Fullerton Rd.
Springfield,  VA  22153
Applicant Contact SANKARA RAMASWAMY
Correspondent
Best Industries
7643 Fullerton Rd.
Springfield,  VA  22153
Correspondent Contact SANKARA RAMASWAMY
Regulation Number892.5730
Classification Product Code
KXK  
Date Received05/07/1993
Decision Date 07/27/1993
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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