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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K212383
Device Name EndoNaut
Therenva SAS
74F rue de Paris
Rennes,  FR 35000
Applicant Contact Audrey Gallois
Therenva SAS
74F rue de Paris
Rennes,  FR 35000
Correspondent Contact Cemil Goksu
Regulation Number892.1650
Classification Product Code
Date Received08/02/2021
Decision Date 08/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No