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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, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K994393
Device Name AEQUALIS UNIVERSAL SHOULDER GLENOID
Applicant
Tornier
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
Tornier
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3660
Classification Product Code
KWS  
Date Received12/28/1999
Decision Date 06/22/2000
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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