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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 K200702
Device Name EasyPath RF Introducer Sheath
Applicant
Broncus Medical, Inc
125 Nicholson Lane
San Jose,  CA  95134
Applicant Contact Robin Bush
Correspondent
Broncus Medical, Inc
125 Nicholson Lane
San Jose,  CA  95134
Correspondent Contact Robin Bush
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
GEI  
Date Received03/18/2020
Decision Date 01/14/2021
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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