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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 K132755
Device Name NEUROMATE FRAMELESS GEN II
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 Received09/03/2013
Decision Date 04/29/2014
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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