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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 K980046
Device Name BRONCHIAL CATHETER SYSTEM
Applicant
BRONCUS TECHNOLOGIES, INC.
1400N SHORELINE BLVD.
BLDG. A, SUITE 8
MOUNTAIN VIEW,  CA  94043
Applicant Contact GLENDON E FRENCH
Correspondent
BRONCUS TECHNOLOGIES, INC.
1400N SHORELINE BLVD.
BLDG. A, SUITE 8
MOUNTAIN VIEW,  CA  94043
Correspondent Contact GLENDON E FRENCH
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
GEI  
Date Received01/06/1998
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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