FDA 510(k) Application Details - K010784

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K010784
Device Name System,Planning,Radiation Therapy Treatment
Applicant NUCLETRON CORP.
7080 COLUMBIA GATEWAY DR.
COLUMBIA, MD 21046 US
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Contact ROBERT APPLEBAUM
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 03/15/2001
Decision Date 04/10/2001
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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