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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 K122704
Device Name BEST LOCALIZATION NEEDLE WITH I-125 SEED
Original Applicant
BEST MEDICAL INTL.
7643 fullerton road
springfield,  VA  22153
Original Contact dharmendra thakur
Regulation Number892.5730
Classification Product Code
KXK  
Date Received09/05/2012
Decision Date 01/09/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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