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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K140478
Device Name AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Applicant Contact MAGALIE HENNEQUIN
Correspondent
Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin,  FR 38330
Correspondent Contact MAGALIE HENNEQUIN
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received02/26/2014
Decision Date 08/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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