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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 K173372
Device Name ExactechGPS Total Shoulder Application
Applicant
Blue Ortho
6 Allee de Bethleem
Gieres,  FR 38610
Applicant Contact Anthony Boyer
Correspondent
Blue Ortho
6 Allee de Bethleem
Gieres,  FR 38610
Correspondent Contact Anthony Boyer
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received10/27/2017
Decision Date 11/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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