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FDA 510(k) Application Details - K142157
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K142157
Device Name
Bone Cement
Applicant
HERAEUS MEDICAL GMBH
PHILIPP-REIS-STR. 8-13
WEHRHEIM 61273 DE
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Contact
ASTRID MARX
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
08/06/2014
Decision Date
09/05/2014
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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