FDA 510(k) Application Details - K983452

Device Classification Name	Prosthesis, Hip, Femoral, Resurfacing   More FDA Info for this Device
510(K) Number	K983452
Device Name	Prosthesis, Hip, Femoral, Resurfacing
Applicant	BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	JULIE K RYAN 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	09/30/1998
Decision Date	12/03/1998
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