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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 K193618
Device Name ExactechGPS System
Applicant
Blue Ortho
6 Allee de Bethleem
Gieres,  FR 38610
Applicant Contact Matthieu Coic
Correspondent
Blue Ortho
6 Allee de Bethleem
Gieres,  FR 38610
Correspondent Contact Matthieu Coic
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/26/2019
Decision Date 09/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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