FDA 510(k) Application Details - K071053

Device Classification Name Prosthesis, Hip, Femoral, Resurfacing

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510(K) Number K071053
Device Name Prosthesis, Hip, Femoral, Resurfacing
Applicant BIOMET, INC.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact BECKY EARL
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Regulation Number 888.3400

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Classification Product Code KXA
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Date Received 04/13/2007
Decision Date 06/29/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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