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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 K181706
Device Name neuromate Gen III
Applicant
Renishaw Mayfield Sarl
31, Rue Ampere
Chassieu,  FR 69680
Applicant Contact Stephane Vinot
Correspondent
Renishaw Mayfield Sarl
31, Rue Ampere
Chassieu,  FR 69680
Correspondent Contact Stephane Vinot
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/28/2018
Decision Date 07/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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