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FDA 510(k) Application Details - K080642
Device Classification Name
More FDA Info for this Device
510(K) Number
K080642
Device Name
COMPREHENSIVE REVERSE SHOULDER
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
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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More FDA Info for this Product Code
Date Received
03/06/2008
Decision Date
07/09/2008
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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