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FDA 510(k) Application Details - K133385
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K133385
Device Name
System, Image Processing, Radiological
Applicant
BRONCUS MEDICAL INC
1400 N. Shoreline Blvd., Bldg A, Suite 8
Mountain View, CA 94043 US
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Contact
ROBIN BUSH
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
11/05/2013
Decision Date
02/26/2014
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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