FDA 510(k) Application Details - K023242

Device Classification Name Source, Brachytherapy, Radionuclide

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510(K) Number K023242
Device Name Source, Brachytherapy, Radionuclide
Applicant IMPLANT SCIENCES CORP.
107 AUDUBON ROAD, #5
WAKEFIELD, MA 01880-1246 US
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Contact JEFFREY GIBBS
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Regulation Number 892.5730

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Classification Product Code KXK
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Date Received 09/30/2002
Decision Date 12/04/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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