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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K213877
Device Name ExactechGPS® System
Applicant
Blue Ortho
22, Chemin du Vieux Chene
Meylan,  FR 38240
Applicant Contact Matthieu Coic
Correspondent
Blue Ortho
22, Chemin du Vieux Chene
Meylan,  FR 38240
Correspondent Contact Matthieu Coic
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/13/2021
Decision Date 05/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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