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FDA 510(k) Application Details - K113121
Device Classification Name
More FDA Info for this Device
510(K) Number
K113121
Device Name
COMPREHENSIVE REVERSE SHOULDER
Applicant
BIOMET MANUFACTURING, INC.
56 EAST BELL DR.
WARSAW, IN 46581-0587 US
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Contact
PATRICIA S BERES
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Regulation Number
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Classification Product Code
PHX
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Date Received
10/21/2011
Decision Date
12/16/2011
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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