FDA 510(k) Application Details - K121874

Device Classification Name

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510(K) Number K121874
Device Name G7 ACETABULAR SYSTEM
Applicant BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact BECKY EARL
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Regulation Number

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Classification Product Code PBI
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Date Received 06/27/2012
Decision Date 11/23/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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