FDA 510(k) Application Details - K042786

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K042786
Device Name Source, Brachytherapy, Radionuclide
Applicant BEST MEDICAL INTERNATIONAL, INC.
7643 FULLERTON RD.
SPRINGFIELD, VA 22153 US
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Contact JOSEPH C WANG
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 10/06/2004
Decision Date 11/18/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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