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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 K924261
Device Name RADIOACTIVE CESIUM-131 SEEDS/SOURCES
Applicant
Best Industries
7643 Fullerton Rd.
Springfield,  VA  22153
Applicant Contact SANKARA I RAMASWAMY
Correspondent
Best Industries
7643 Fullerton Rd.
Springfield,  VA  22153
Correspondent Contact SANKARA I RAMASWAMY
Regulation Number892.5730
Classification Product Code
KXK  
Date Received08/24/1992
Decision Date 06/04/1993
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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