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FDA 510(k) Application Details - K012551

Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer

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510(K) Number K012551
Device Name Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW, IN US
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Contact PATRICIA SANDBORN BERES
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Regulation Number 888.3170

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Classification Product Code KWI
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Date Received 08/07/2001
Decision Date 01/30/2002
Decision SE - Substantially Equivalent
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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