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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 K013111
Device Name EXHALE PROBE
Applicant
Broncus Technologies, Inc.
1400 N. Shoreline Blvd.,
#A8
Mountain View,  CA  94043
Applicant Contact TIMOTHY R WILLIAMS
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Codes
ITX   IYO  
Date Received09/18/2001
Decision Date 10/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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