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FDA 510(k) Application Details - K050855
Device Classification Name
Bone Cement
More FDA Info for this Device
510(K) Number
K050855
Device Name
Bone Cement
Applicant
HERAEUS KULZER GMBH
PHILLIP REIS-STRASSE 8/13
WEHRHEIM D-61273 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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/04/2005
Decision Date
07/07/2005
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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