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FDA 510(k) Application Details - K032550
Device Classification Name
System, Simulation, Radiation Therapy
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
892.5840
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Classification Product Code
KPQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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