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FDA 510(k) Application Details - K121183
Device Classification Name
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510(K) Number
K121183
Device Name
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
Applicant
BIOMET CORPORATION
56 EAST BELL DRIVE
WARSAW, IN 46580 US
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Contact
PATRICIA SANDBORN BERES
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Regulation Number
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Classification Product Code
PHX
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Date Received
04/18/2012
Decision Date
07/26/2012
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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