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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K212886
Device Name Broncoflex Agile, Broncoflex Vortex, Screeni
Applicant
Axess Vision Technology
Zone De La Liodière 6, Rue De La Flottière
Joué-Lès-Tours,  FR 37300
Applicant Contact Marie-Hélène Bacheley
Correspondent
Axess Vision Technology
Zone De La Liodière 6, Rue De La Flottière
Joué-Lès-Tours,  FR 37300
Correspondent Contact Marie-Hélène Bacheley
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received09/10/2021
Decision Date 02/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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