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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, Femoral, Resurfacing
510(k) Number K071053
Device Name RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact BECKY EARL
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact BECKY EARL
Regulation Number888.3400
Classification Product Code
KXA  
Date Received04/13/2007
Decision Date 06/29/2007
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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