FDA 510(k) Application Details - K043542

Device Classification Name	Prosthesis, Hip, Femoral, Resurfacing   More FDA Info for this Device
510(K) Number	K043542
Device Name	Prosthesis, Hip, Femoral, Resurfacing
Applicant	BIOPRO, INC. 17 SEVENTEENTH ST. PORT HURON, MI 48060 US Other 510(k) Applications for this Company
Contact	DAVID MRAK Other 510(k) Applications for this Contact
Regulation Number	888.3400   More FDA Info for this Regulation Number
Classification Product Code	KXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2004
Decision Date	05/18/2005
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