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FDA 510(k) Application Details - K242324
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K242324
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
Novatech SA
Z.I. AthΘlia III -1058, Voie Antiope
La Ciotat CEDEX 13705 FR
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Contact
Stuart K. Montgomery
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
08/06/2024
Decision Date
02/06/2025
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
FDA Source Information for K242324
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