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FDA 510(k) Application Details - K232038
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K232038
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Broncus Medical, Inc.
125 Nicholson Lane
San Jose, CA 95134 US
Other 510(k) Applications for this Company
Contact
Charles Ogbonna
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/10/2023
Decision Date
04/26/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K232038
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