FDA 510(k) Application Details - K071569

Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue

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510(K) Number K071569
Device Name Fastener, Fixation, Nondegradable, Soft Tissue
Applicant BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW, IN 46581-0587 US
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Contact ELIZABETH WRAY
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Regulation Number 888.3040

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Classification Product Code MBI
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Date Received 06/08/2007
Decision Date 07/02/2007
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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