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FDA 510(k) Application Details - K080888
Device Classification Name
System,Planning,Radiation Therapy Treatment
More FDA Info for this Device
510(K) Number
K080888
Device Name
System,Planning,Radiation Therapy Treatment
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
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Contact
CARSTEN RAUPACH
Other 510(k) Applications for this Contact
Regulation Number
892.5050
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Classification Product Code
MUJ
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More FDA Info for this Product Code
Date Received
03/31/2008
Decision Date
06/11/2008
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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