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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K011942
Device Name AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
Applicant
Tornier
Rue Doyen Gosse
St. Ismier,  FR 38330
Applicant Contact IRENE GOSSET
Correspondent
Tornier
Rue Doyen Gosse
St. Ismier,  FR 38330
Correspondent Contact IRENE GOSSET
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received06/21/2001
Decision Date 07/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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