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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 K202547
Device Name Surgivisio system
Applicant
Surgivisio
Zone Mayencin II, Parc Equation - Bâtiment 1,
2 avenue de Vignate
Gières,  FR 38610
Applicant Contact Vincent Lere
Correspondent
Surgivisio
Zone Mayencin II, Parc Equation - Bâtiment 1,
2 avenue de Vignate
Gières,  FR 38610
Correspondent Contact Elodie Bouillet
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received09/02/2020
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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