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FDA 510(k) Application Details - K121874
Device Classification Name
More FDA Info for this Device
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
More FDA Info for this Regulation Number
Classification Product Code
PBI
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More FDA Info for this Product Code
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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