FDA 510(k) Application Details - K010586

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K010586
Device Name	Bone Cement
Applicant	MERCK BIOMATERIAL GMBH FRANKFURTER STR. 250, D-64271 DARMSTADT D-64271 DE Other 510(k) Applications for this Company
Contact	THOMAS KIEWITT 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	02/27/2001
Decision Date	10/30/2001
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