FDA 510(k) Application Details - K092773

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K092773
Device Name	Bone Cement
Applicant	TECRES SPA 7 Trail House Court Rockville, MD 20850 US Other 510(k) Applications for this Company
Contact	CHRISTINE BRAUER 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	09/09/2009
Decision Date	11/24/2009
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