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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 K050316
Device Name AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant
TORNIER
161 RUE LAVOISIER
MONTBONNOT, SAINT-ISMIER,  FR 38334
Applicant Contact Mireille Lemery
Correspondent
TORNIER
161 RUE LAVOISIER
MONTBONNOT, SAINT-ISMIER,  FR 38334
Correspondent Contact Mireille Lemery
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received02/09/2005
Decision Date 03/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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