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FDA 510(k) Application Details - K021715
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K021715
Device Name
Bone Cement
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE, FL 32653 US
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Contact
GARY J MILLER
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
05/23/2002
Decision Date
06/12/2002
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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