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FDA 510(k) Application Details - K100056
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K100056
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
MEDCOM GMBH
12 RUNDETURMSTRASSE
DARMSTADT, HESSEN 64283 DE
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Contact
STEFAN WALTER
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
MUJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/08/2010
Decision Date
05/07/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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