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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, Porous Uncemented
510(k) Number K000538
Device Name MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
Applicant
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact DALENE T BINKLEY
Correspondent
Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3358
Classification Product Code
LPH  
Date Received02/17/2000
Decision Date 03/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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