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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 K182417
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 Received09/05/2018
Decision Date 02/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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