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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 K214065
Device Name ROSA ONE Brain application
Applicant
Medtech S.A.S
432 Rue Du Rajol
Mauguio,  FR 34130
Applicant Contact Paul Hardy
Correspondent
Medtech S.A.S
432 Rue Du Rajol
Mauguio,  FR 34130
Correspondent Contact Paul Hardy
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/27/2021
Decision Date 05/04/2022
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
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