FDA 510(k) Application Details - K200702

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K200702
Device Name Bronchoscope (Flexible Or Rigid)
Applicant Broncus Medical, Inc
125 Nicholson Lane
San Jose, CA 95134 US
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Contact Robin Bush
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 03/18/2020
Decision Date 01/14/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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