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FDA 510(k) Application Details - K031673
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K031673
Device Name
Bone Cement
Applicant
HERAEUS KULZER GMBH & CO. KG
GRUNER WEG 11
HANAU D-63450 DE
Other 510(k) Applications for this Company
Contact
K.-D. KUHN
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
05/30/2003
Decision Date
05/25/2004
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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