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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K091160
Device Name LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
Applicant
Broncus Technologies, Inc.
1400 N. Shoreline Blvd., Bldg. A, Suite 8
Mountain View,  CA  94043
Applicant Contact MAHTAB FATEMI
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/21/2009
Decision Date 05/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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