FDA 510(k) Application Details - K073018

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K073018
Device Name Accelerator, Linear, Medical
Applicant BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
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Contact RAINER BIRKENBACH
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 10/25/2007
Decision Date 01/23/2008
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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