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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K030047
Device Name FREEDOM CONSTRAINED LINERS
Applicant
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact MAX T HEBEL
Correspondent
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact MAX T HEBEL
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received01/06/2003
Decision Date 01/23/2003
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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