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FDA 510(k) Application Details - K033596
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K033596
Device Name
Bone Cement
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
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Contact
GARY MILLER
Other 510(k) Applications for this Contact
Regulation Number
888.3027
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Classification Product Code
LOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2003
Decision Date
05/10/2004
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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