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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurological stereotaxic instrument
510(k) Number K200511
Device Name ROSA ONE Brain application
Applicant
Medtech S.A.
ZAC Eureka - 900 Rue du Mas de Verchant
Montpellier,  FR 34000
Applicant Contact Serge Tabet
Correspondent
Medtech S.A.
ZAC Eureka - 900 Rue du Mas de Verchant
Montpellier,  FR 34000
Correspondent Contact Serge Tabet
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/02/2020
Decision Date 05/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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