FDA 510(k) Application Details - K001660

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

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510(K) Number K001660
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant BIOMET ORTHOPEDICS, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact MICHELLE L MCKINLEY
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 05/31/2000
Decision Date 06/14/2000
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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