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FDA 510(k) Application Details - K200702
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
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More FDA Info for this Product Code
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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