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FDA 510(k) Application Details - K082300
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K082300
Device Name
Plate, Fixation, Bone
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact
SUZANA OTANO
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/12/2008
Decision Date
02/18/2009
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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