FDA 510(k) Application Details - K033509

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K033509
Device Name	Bone Cement
Applicant	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	DAVID HENLEY 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	11/06/2003
Decision Date	11/28/2003
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