FDA 510(k) Application Details - K060912

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K060912
Device Name Accelerator, Linear, Medical
Applicant TOMOTHERAPY INCORPORATED
1240 DEMING WAY
MADISON, WI 53717 US
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Contact KENNETH D BUROKER
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 04/03/2006
Decision Date 04/19/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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