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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 K011267
Device Name EXHALE RF PROBE
Applicant
BRONCUS TECHNOLOGIES, INC.
1400N SHORELINE BLVD.
BLDG. A, SUITE 8
mountain view,  CA  94043
Applicant Contact tim r williams
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
new brighton,  MN  55112 -1891
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/26/2001
Decision Date 05/08/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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