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FDA 510(k) Application Details - K050085
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K050085
Device Name
Bone Cement
Applicant
HERAEUS KULZER GMBH
GRUNER WEG 11
HANAU 63450 DE
Other 510(k) Applications for this Company
Contact
CHRISTIAN TUCHSCHERER
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
01/13/2005
Decision Date
09/14/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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