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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 K171829
Device Name EndoNaut
Therenva SAS
4 rue Jean Jaures
Rennes,  FR 35000
Applicant Contact Matthis HAMY
Therenva SAS
4 rue Jean Jaures
Rennes,  FR 35000
Correspondent Contact Matthis HAMY
Regulation Number892.1650
Classification Product Code
Date Received06/20/2017
Decision Date 09/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No