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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, Non-Constrained, Metal/Polymer Cemented
510(k) Number K022079
Device Name SHORT AND LONG SOFT TISSUE ATTACHMENT
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact KACY ARNOLD
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact KACY ARNOLD
Regulation Number888.3650
Classification Product Code
KWT  
Date Received06/26/2002
Decision Date 09/24/2002
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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