FDA 510(k) Application Details - K032790

Device Classification Name Block, Beam-Shaping, Radiation Therapy

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510(K) Number K032790
Device Name Block, Beam-Shaping, Radiation Therapy
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 NELSON AVE.
CONCORD, CA 94520 US
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Contact KEN NEHMER
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Regulation Number 892.5710

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Classification Product Code IXI
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Date Received 09/08/2003
Decision Date 10/02/2003
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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