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FDA 510(k) Application Details - K143100
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K143100
Device Name
Bone Cement
Applicant
Cossington Ltd
167-169 London Road
Kingston Upon Thames KT26PT GB
Other 510(k) Applications for this Company
Contact
Diana Mandell Horwitz, Ph.D.,RAC
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
10/28/2014
Decision Date
03/05/2015
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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