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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 K040610
Device Name VERSA-DIAL HUMERAL HEAD
Applicant
Biomet Manufacturing, Inc.
P.O. Box 587
Warsaw,,  IN  46581 -0578
Applicant Contact GARY BAKER
Correspondent
Biomet Manufacturing, Inc.
P.O. Box 587
Warsaw,,  IN  46581 -0578
Correspondent Contact GARY BAKER
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
HSD   KWT   MBF  
Date Received03/08/2004
Decision Date 06/04/2004
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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