FDA 510(k) Application Details - K092285

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K092285
Device Name Accelerator, Linear, Medical
Applicant BEST MEDICAL CANADA LTD.
413 MARCH ROAD
OTTAWA, ONTARIO K2K 034 CA
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Contact MARY HERBERT
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 07/29/2009
Decision Date 08/28/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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