FDA 510(k) Application Details - K000137

Device Classification Name Block, Beam-Shaping, Radiation Therapy

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510(K) Number K000137
Device Name Block, Beam-Shaping, Radiation Therapy
Applicant COMPUTERIZED MEDICAL SYSTEMS, INC.
1195 CORPORATE LAKE DR.
ST. LOUIS, MO 63132-1716 US
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Contact MICHAEL A PARSONS
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Regulation Number 892.5710

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Classification Product Code IXI
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Date Received 01/18/2000
Decision Date 04/17/2000
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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