FDA 510(k) Application Details - K020027

Device Classification Name System,Planning,Radiation Therapy Treatment

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510(K) Number K020027
Device Name System,Planning,Radiation Therapy Treatment
Applicant COMPUTERIZED MEDICAL SYSTEMS, INC.
1145 CORPORATE LAKE DR.
ST. LOUIS, MO 63132-1716 US
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Contact MICHAEL A PARSONS
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Regulation Number 892.5050

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Classification Product Code MUJ
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Date Received 01/04/2002
Decision Date 10/08/2002
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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