FDA 510(k) Application Details - K082468

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented   More FDA Info for this Device
510(K) Number	K082468
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Applicant	OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE RAYNHAM, MA 02767 US Other 510(k) Applications for this Company
Contact	WILLIAM MCCALLUM Other 510(k) Applications for this Contact
Regulation Number	888.3390   More FDA Info for this Regulation Number
Classification Product Code	KWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2008
Decision Date	02/18/2009
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