FDA 510(k) Application Details - K123371

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K123371
Device Name Accelerator, Linear, Medical
Applicant VISION RT LIMITED
Dove House
Arcadia Avenue
LONDON N3 2JU GB
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Contact NORMAN SMITH
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 11/01/2012
Decision Date 01/08/2013
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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