FDA 510(k) Application Details - K052255

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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510(K) Number K052255
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW, IN 46582 US
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Contact ALLISON K KOSKEY
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 08/18/2005
Decision Date 11/23/2005
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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