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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bronchoscope (flexible or rigid)
510(k) Number K131234
FOIA Releasable 510(k) K131234
Device Name LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
Applicant
BRONCUS MEDICAL INC
1400 N. Shoreline Blvd., Bldg A, Suite 8
Mountain View,  CA  94043
Applicant Contact MAHTAB FATEMI
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/01/2013
Decision Date 10/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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