FDA 510(k) Application Details - K121663

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K121663
Device Name Accelerator, Linear, Medical
Applicant ELEKTA LTD.
2050 BLEURY, SUITE 200
MONTREAL H3A 2J5 CA
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Contact GEORGE PAPAGIANNIS
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 06/05/2012
Decision Date 12/05/2012
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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