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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 Ave. De Vignate
Gieres,  FR 38610
Applicant Contact Vincent Lere
Correspondent
Surgivisio
Zone Mayencin Ii, Parc Equation - Bâtiment 1,
2 Ave. De Vignate
Gieres,  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
Predetermined Change
Control Plan Authorized		 No
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