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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 K220946
Device Name SURGIVISIO Device
Applicant
Ecential Robotics
Zone Mayencin Ii, Parc Equation - Bâtiment 1,
2 Ave. De Vignate
Gieres,  FR 38610
Applicant Contact Mathilde Saulpic
Correspondent
Ecential Robotics
Zone Mayencin Ii, Parc Equation - Bâtiment 1,
2 Ave. De Vignate
Gieres,  FR 38610
Correspondent Contact Mathilde Saulpic
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received04/01/2022
Decision Date 04/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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