FDA 510(k) Application Details - K032724

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K032724
Device Name System,Planning,Radiation Therapy Treatment
Applicant ADAC LABORATORIES
6400 ENTERPRISE LANE,STE.201
MADISON, WI 53719 US
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Contact RANDY VADER
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 09/03/2003
Decision Date 10/09/2003
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 Y
Expedited Review



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