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FDA 510(k) Application Details - K120121
Device Classification Name
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510(K) Number
K120121
Device Name
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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PATRICIA BERES
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Regulation Number
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Classification Product Code
PHX
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Date Received
01/17/2012
Decision Date
02/16/2012
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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