FDA 510(k) Application Details - K013755

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K013755
Device Name	Bone Cement
Applicant	IMMEDICA, INC. 615 7TH ST. NE WASHINGTON, DC 20002 US Other 510(k) Applications for this Company
Contact	RUSSELL PAGANO 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	11/13/2001
Decision Date	02/08/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review