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FDA 510(k) Application Details - K092653
Device Classification Name
System, Radiation Therapy, Charged-Particle, Medical
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510(K) Number
K092653
Device Name
System, Radiation Therapy, Charged-Particle, Medical
Applicant
MEDCOM GMBH
12 RUNDETURMSTRASSE
DARMSTADT, HESSEN 64283 DE
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Contact
STEFAN WALTER
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Regulation Number
892.5050
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Classification Product Code
LHN
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More FDA Info for this Product Code
Date Received
08/28/2009
Decision Date
09/18/2009
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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