FDA 510(k) Application Details - K030047

Device Classification Name Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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510(K) Number K030047
Device Name Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact MAX T HEBEL
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Regulation Number 888.3310

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Classification Product Code KWZ
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Date Received 01/06/2003
Decision Date 01/23/2003
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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