FDA 510(k) Application Details - K001160

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K001160
Device Name	Bone Cement
Applicant	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	EHAB M ESMAIL 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	04/10/2000
Decision Date	12/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review