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FDA 510(k) Application Details - K142108
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K142108
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
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Contact
ALEXANDER SCHWIERSCH
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
08/04/2014
Decision Date
12/16/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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