FDA 510(k) Application Details - K123808

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K123808
Device Name Accelerator, Linear, Medical
Applicant ELEKTA LTD.
FLEMING WAY
LINAC HOUSE
CRAWLEY, WEST SUSSEX RH10 9RR GB
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Contact Patrick Hull
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 12/11/2012
Decision Date 04/04/2013
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 N
Expedited Review



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