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FDA 510(k) Application Details - K072804
Device Classification Name
More FDA Info for this Device
510(K) Number
K072804
Device Name
COMPREHENSIVE RS SHOULDER SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. 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
10/01/2007
Decision Date
12/12/2007
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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