FDA 510(k) Application Details - K020015

Device Classification Name System, Applicator, Radionuclide, Remote-Controlled

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510(K) Number K020015
Device Name System, Applicator, Radionuclide, Remote-Controlled
Applicant NUCLETRON CORP.
7080 COLUMBIA GATEWAY DR.
COLUMBIA, MD 21046 US
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Contact LISA DIMMICK
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Regulation Number 892.5700

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Classification Product Code JAQ
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Date Received 01/03/2002
Decision Date 03/13/2002
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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