FDA 510(k) Application Details - K032550

Device Classification Name System, Simulation, Radiation Therapy

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510(K) Number K032550
Device Name System, Simulation, Radiation Therapy
Applicant MEDCOM GMBH
RUNDETURMSTR. 12
DARMSTADT, HESSEN 64283 DE
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Contact STEFAN WALTER
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Regulation Number 892.5840

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Classification Product Code KPQ
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Date Received 08/18/2003
Decision Date 09/25/2003
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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