FDA 510(k) Application Details - K022251

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K022251
Device Name	Bone Cement
Applicant	HERAEUS KULZER GMBH & CO. KG GRUNER WEG 11 HANAU D-63450 DE Other 510(k) Applications for this Company
Contact	K. D. KUHN 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	07/12/2002
Decision Date	02/26/2003
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