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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, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K033871
Device Name IM TOTAL FEMUR
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JWH   KRO  
Date Received12/12/2003
Decision Date 04/16/2004
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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