FDA 510(k) Application Details - K090095

Device Classification Name System, Image Processing, Radiological

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510(K) Number K090095
Device Name System, Image Processing, Radiological
Applicant BRONCUS TECHNOLOGIES, INC.
1400 NORTH SHORELINE BLVD.,
SUITE 8
MOUNTAIN VIEW, CA 94043-1346 US
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Contact MAHTAB FATEMI
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/15/2009
Decision Date 03/13/2009
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 Y
Expedited Review



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