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FDA 510(k) Application Details - K053003
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K053003
Device Name
Bone Cement
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact
NATALIE S HECK
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
LOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/26/2005
Decision Date
11/22/2005
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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