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FDA 510(k) Application Details - K172408
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K172408
Device Name
Bone Cement
Applicant
Biomet Inc
56 East Bell Drive
Warsaw, IN 46581 US
Other 510(k) Applications for this Company
Contact
Heidi Busz
Other 510(k) Applications for this Contact
Regulation Number
888.3027
More FDA Info for this Regulation Number
Classification Product Code
LOD
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More FDA Info for this Product Code
Date Received
08/09/2017
Decision Date
10/05/2017
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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