FDA 510(k) Application Details - K040688

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K040688
Device Name System,Planning,Radiation Therapy Treatment
Applicant STANDARD IMAGING, INC.
7601 MURPHY DR.
MIDDLETON, WI 53562-2766 US
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Contact RAYMOND T RIDDLE
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 03/16/2004
Decision Date 05/11/2004
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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