FDA 510(k) Application Details - K242324

Device Classification Name Bronchoscope (Flexible Or Rigid)

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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
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Regulation Number 874.4680

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Classification Product Code EOQ
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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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