FDA 510(k) Application Details - K954861

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K954861
Device Name Accelerator, Linear, Medical
Applicant BRAINLAB MED. COMPUTERSYSTEME GMBH
GRUBER STRABE 46C
85586 POING/MUNCHEN 85586 DE
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Contact MICHAEL BERTRAM
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 10/23/1995
Decision Date 08/05/1996
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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