FDA 510(k) Application Details - K030609

Device Classification Name Block, Beam-Shaping, Radiation Therapy

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510(K) Number K030609
Device Name Block, Beam-Shaping, Radiation Therapy
Applicant MRC SYSTEMS GMBH
HANS-BUNTE-STR. 10
HEIDELBERG D-69123 DE
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Contact JOERG STEIN
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Regulation Number 892.5710

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Classification Product Code IXI
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Date Received 02/26/2003
Decision Date 03/17/2003
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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