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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 K993900
FOIA Releasable 510(k) K993900
Device Name COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
Applicant
Broncus Technologies, Inc.
1400 N. Shoreline Blvd., Bldg. A, Suite 8
Mountain View,  CA  94043
Applicant Contact JOHN D'ANGELO
Correspondent
Broncus Technologies, Inc.
1400 N. Shoreline Blvd., Bldg. A, Suite 8
Mountain View,  CA  94043
Correspondent Contact JOHN D'ANGELO
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
GEI  
Date Received11/16/1999
Decision Date 01/28/2000
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
Predetermined Change
Control Plan Authorized		 No
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