FDA 510(k) Application Details - K011024

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K011024
Device Name Accelerator, Linear, Medical
Applicant ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE, CA 94085 US
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Contact E. BRUCE FLOYD
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 04/04/2001
Decision Date 08/10/2001
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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