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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 K172444
Device Name ROSA BRAIN (v3.0.0.5)
Applicant
MEDTECH S.A.
ZAC Eureka - 900 Rue Du Mas De Verchant
Montpellier,  FR 34000
Applicant Contact Elise Lagacherie
Correspondent
MEDTECH S.A.
ZAC Eureka - 900 Rue Du Mas De Verchant
Montpellier,  FR 34000
Correspondent Contact Elise Lagacherie
Regulation Number882.4560
Classification Product Code
HAW  
Date Received08/14/2017
Decision Date 03/28/2018
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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