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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 K100742
Device Name EXACTECH GPS
Applicant
Blue Ortho
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Applicant Contact ANTHONY BOYER
Correspondent
Blue Ortho
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Correspondent Contact ANTHONY BOYER
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
HAW  
Date Received03/16/2010
Decision Date 10/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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