FDA 510(k) Application Details - K073273

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K073273
Device Name Accelerator, Linear, Medical
Applicant NUCLETRON CORPORATION
8671 ROBERT FULTON DR.
COLUMBIA, MD 21046-2133 US
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Contact LISA DIMMICK
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 11/21/2007
Decision Date 12/11/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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