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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K093549
FOIA Releasable 510(k) K093549
Device Name 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
Applicant
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact BECKY EARL
Correspondent
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact BECKY EARL
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   LPH   LWJ   MAY  
Date Received11/17/2009
Decision Date 12/16/2009
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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