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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 K152764
Device Name EXACTECH GPS
Applicant
BLUE ORTHO
5 AVENUE DU GRAND SABLON
LA TRONCHE,  FR 38700
Applicant Contact ANTHONY BOYER
Correspondent
BLUE ORTHO
5 AVENUE DU GRAND SABLON
LA TRONCHE,  FR 38700
Correspondent Contact ANTHONY BOYER
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/24/2015
Decision Date 07/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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